ICQ Consultants is recruiting Computer System Validation (CSV) Engineers in New England.

To support current and future projects, ICQ Consultants is actively recruiting Computer System Validation (CSV) Engineers.  We currently have multiple opportunities available in New England.

ICQ offers some of the most competitive benefits and wages in our segment of service providers which include the following:

    • Tufts Health Insurance, Delta Dental  – Paid 100% by ICQ, no employee premium.
    • Paid time off for Holidays, Sick Time and Vacation
    • 401K with a 100% match up to 4%
    • Short term / Long Term Disability – Paid 100% by ICQ
    • Life insurance – Paid 100% by ICQ
    • Reimbursed Project Specific Travel & Business Expenses 

Positions report to the assigned manager and applicants are responsible for developing and executing protocols, including test functions, calibration, and sampling.  Must maintain compliance with the company’s Standard Operating Procedures and Policies.

EDUCATION/EXPERIENCE REQUIREMENTS

  • B.S. degree in Biology, Biochemistry, Chemistry, Engineering or related experience in FDA-regulated industries working in QC, Manufacturing, Engineering, QA and/or Validation.
  • Experience or a demonstrated ability to perform the responsibilities of the position in leading, planning, and execution of projects involving in one or more of the following:
    • 3+ years Computer Systems / Automation Experience.
    • 3+ years Process Manufacturing Experience.
    • 3+ years Commissioning, Qualification and Validation of Utilities, Facilities, Processes and Process Equipment.

RESPONSIBILITIES

  • Act as a computerized/automated systems project lead.
  • Provide quality oversight and compliance support to implement and validate electronic systems in accordance with the client’s computer systems validation procedures and requirements.
  • Provide QA oversight during regulatory assessments, risk assessments, 21 CFR Part 11 and Annex 11 assessments.
  • Develop or Review Validation Plans, Specifications, Installations Qualification Protocols, Operational Qualification Protocols, Performance Qualifications Protocols, and Summary Reports associated with computer systems.
  • Support and review system administration and maintenance procedures to ensure computer systems are in a state of control
  • Act in a leadership capacity: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, etc.

DESIRED SKILLS AND EXPERIENCE

  • Understanding of GxP and Computer Systems / Automation role in support of GxP compliance is required
  • Knowledge and understanding of relevant regulations, such as Part 11, Annex 11, Part 211, etc., is required
  • Experience with manufacturing automation systems is highly desired
  • Specific experience in Cell Culture, Chromatography, UF/DF, and filtration processes and equipment.
  • Previous Project Management Experience.
  • Proficiency with Microsoft Office & Delta V.
  • Ability to deliver results is a must.
  • Only local candidates will be considered.

If you are interested in learning more about current opportunities, contact us directly at [email protected]

 

ICQ Consultants is recruiting Cleaning Validation Engineers in the Greater Boston area.

To support current and future projects, ICQ Consultants is actively recruiting Cleaning Validation Subject Matter Experts.  We currently have multiple opportunities available in the Greater Boston Area.

ICQ offers some of the most competitive benefits and wages in our segment of service providers which include the following:

    • Tufts Health Insurance, Delta Dental  – Paid 100% by ICQ, no employee premium.
    • Paid time off for Holidays, Sick Time and Vacation
    • 401K with a 100% match up to 4%
    • Short term / Long Term Disability – Paid 100% by ICQ
    • Life insurance – Paid 100% by ICQ
    • Reimbursed Project Specific Travel & Business Expenses 

Positions report to the assigned manager and applicants are responsible for developing and executing protocols, including test functions, calibration, and sampling.  Must maintain compliance with the company’s Standard Operating Procedures and Policies.

EDUCATION/EXPERIENCE REQUIREMENTS

  • B.S. degree in Biology, Biochemistry, Chemistry, Engineering or related experience in FDA-regulated industries working in QC, Manufacturing, Engineering, QA and/or Validation.
  • Experience or a demonstrated ability to perform the responsibilities of the position in leading, planning, and execution of projects involving in one or more of the following:
    • 5+ years Process Manufacturing Experience.
    • 5+ years Commissioning, Qualification and Validation of Utilities, Facilities, Processes and Process Equipment.

RESPONSIBILITIES

  • Generate, review, approve, and execute process, facility, and cleaning validations.
  • Supports the facility equipment cleaning validation program, creates and maintains SOPs for cleaning validation program.
  • Assist engineering with equipment qualifications by participating in FATs, commissioning activities, SATs, and IOPQ events.
  • Conducts or coordinates performance qualification execution for new or existing equipment.
  • Active communication with management, clients, and project team members.
  • Participate in training to ensure continued accreditation.
  • Other tasks as required by department management.
  • Travel may be required.

DESIRED SKILLS AND EXPERIENCE

  • Considered a Subject Matter Expert (SME) in cleaning validation.
  • Specific experience in Cell Culture, Chromatography, UF/DF, and filtration processes and equipment.
  • Previous Project Management Experience.
  • Proficiency with Microsoft Office & Delta V.
  • Customarily and regularly exercises discretionary powers and independent judgment in performing the job.
  • Excellent Communication Skills.
  • Ability to handle many tasks with limited direction.
  • Ability to deliver results is a must.

Only local candidates will be considered.

If you are interested in learning more about current opportunities, contact us directly at [email protected]

 

If you’re looking to join a winning team, check us out, we are hiring. ICQ is recruiting Process Validation Engineers in the Greater Boston Area.

If you are considering a career change, we would love to hear from you.  ICQ is actively recruiting highly motivated professionals to join our team.  We currently have multiple opportunities available in the Greater Boston Area.

ICQ offers some of the most competitive benefits and wages in our segment of service providers which include the following:

    • Tufts Health Insurance, Delta Dental  – Paid 100% by ICQ, no employee premium.
    • Paid time off for Holidays, Sick Time and Vacation
    • 401K with a 100% match up to 4%
    • Short term / Long Term Disability – Paid 100% by ICQ
    • Life insurance – Paid 100% by ICQ
    • Reimbursed Project Specific Travel & Business Expenses 

Positions report to the assigned manager and applicants are responsible for developing and executing protocols, including test functions, calibration, and sampling.  Must maintain compliance with the company’s Standard Operating Procedures and Policies.

EDUCATION/EXPERIENCE REQUIREMENTS

  • B.S. degree in Biology, Biochemistry, Chemistry, Engineering or related experience in FDA-regulated industries working in QC, Manufacturing, Engineering, QA and/or Validation.
  • Experience or a demonstrated ability to perform the responsibilities of the position in leading, planning, and execution of projects involving in one or more of the following:
    • 3+ years Process Manufacturing Experience.
    • 3+ years Commissioning, Qualification and Validation of Utilities, Facilities, Processes and Process Equipment.

RESPONSIBILITIES

  • Develop and execute validation plans, test plans, validation protocols, and procedures.
  • Customarily and regularly exercises discretionary powers and independent judgment in performing the job.
  • Work as a leader to develop protocols and procedures, execute same including test functions, sampling, and calibration.
  • Communication with management, clients, and project team members.
  • Participate in training to ensure continued accreditation.
  • Other tasks as required by department management.
  • Travel may be required.

DESIRED SKILLS AND EXPERIENCE

  • Equipment Validation Experience (incubators, refrigerators/freezers, cold rooms).
  • Ability to plan and execute Smoke / Airflow Visualization Studies.
  • Specific experience in Cell Culture, Chromatography, UF/DF, and filtration processes.
  • Ability to function as a Technical Equipment Validation Lead.
  • Previous Project Management Experience.
  • Strong background in MS Word and MS Excel.
  • Excellent Communication Skills.
  • Ability to handle many tasks with limited direction.
  • Ability to deliver results is a must.

Only local candidates will be considered.

If you are interested in learning more about current opportunities, contact us directly at [email protected]

 

ICQ Consultants is hiring Senior Project Managers in Boston MA.

ICQ Consultants is working to support current and future construction projects in Boston Massachusetts.  If you are considering a career change, we would love to hear from you.  ICQ is actively recruiting highly motivated professionals to join our team.

ICQ offers some of the most competitive benefits and wages in our segment of service providers which include the following:

    • Tufts Health Insurance, Delta Dental  – Paid 100% by ICQ, no employee premium.
    • Paid time off for Holidays, Sick Time and Vacation
    • 401K with a 100% match up to 4%
    • Short term / Long Term Disability – Paid 100% by ICQ
    • Life insurance – Paid 100% by ICQ
    • Reimbursed Project Specific Travel & Business Expenses 

EDUCATION/EXPERIENCE REQUIREMENTS

  • B.S. degree with 8+ years or M.S. with 5+ years in a related field, PMP certification preferred.
  • Background in Biology, Biochemistry, Chemistry, Engineering or related experience in FDA-regulated industries working in QC, Manufacturing, Engineering, QA and/or Validation.
  • Previous experience successfully managing multiple / integration projects required.
  • 5+ years of relevant experience as a Project Manager.

RESPONSIBILITIES

  • Identify project goals and objectives, scope definition, project execution strategy, project risk management, change management, and other associated activities.
  • Coordination of Engineering schedule, defining review and approval cycles, Engineering BOD, Detailed Design and turn over packages.
  • Overseeing Construction Management contract, construction budget and schedule, construction quality plan, and staffing plan.
  • Coordination of Commissioning and Qualification activities, development of URS’s, Validation Plans, Risk Assessments, consult on Commissioning Protocol development, and functional impact.
  • Customarily and regularly exercises discretionary powers and independent judgment in performing the job.
  • Communication with management, clients, and project team members.
  • Participate in training to ensure continued accreditation.
  • Other tasks as required by department management.

DESIRED SKILLS AND EXPERIENCE

  • Strong interpersonal and communication skills with demonstrated ability to work within a team environment.
  • Excellent troubleshooting skills; ability to react quickly to understand and solve problems.
  • Knowledge of project management processes. Ability to understand and manage project plans, budgets, constraints, and schedules.
  • Knowledge of industry standards and guidelines, such as – ASME, BPE, ISPE Baseline Guides, CFR’s, OSHA, International standards, etc.

Only local candidates will be considered.

If you are interested in learning more about current opportunities, contact us directly at [email protected]

 

ICQ Consultants continues to expand, hiring for QA Supply Chain Specialist in Boston MA.

ICQ Consultants is working to support current and future projects in Boston Massachusetts.  If you are considering a career change, we would love to hear from you.  ICQ is actively recruiting highly motivated professionals to join our team.

ICQ offers some of the most competitive benefits and wages in our segment of service providers which include the following:

    • Tufts Health Insurance, Delta Dental  – Paid 100% by ICQ, no employee premium.
    • Paid time off for Holidays, Sick Time and Vacation
    • 401K with a 100% match up to 4%
    • Short term / Long Term Disability – Paid 100% by ICQ
    • Life insurance – Paid 100% by ICQ
    • Reimbursed Project Specific Travel & Business Expenses 

EDUCATION/EXPERIENCE REQUIREMENTS

  • B.S. degree in Biology, Biochemistry, Chemistry, Engineering or related experience in FDA-regulated industries working in QC, Manufacturing, Engineering, QA and/or Validation.
  • Experience or a demonstrated ability to perform the responsibilities of the position in leading, planning, and execution of projects involving one or more of the following:
    • 3 + years cGMP Material Management compliance

RESPONSIBILITIES

  • Provide technical expertise in material management and warehousing including quality and compliance standards, testing, qualification, and release.
  • Perform Vendor and Material Qualification activities for domestic and international suppliers of raw materials as required.
  • Develop and execute validation plans, test plans, validation protocols, and procedures.
  • Customarily and regularly exercises discretionary powers and independent judgment in performing the job.
  • Work as a leader, part of validation team, or independently to develop protocols and procedures, execute same including test functions, sampling, and calibration.
  • Communication with management, clients, and project team members.
  • Participate in training to ensure continued accreditation.
  • Other tasks as required by department management.

DESIRED SKILLS AND EXPERIENCE

  • Experience in Quality Control, Quality Assurance, cGMP environments.
  • Established background in Materials Management.
  • Established background in raw material methods, and specifications.
  • Expertise in ICH, USP/EP/JP standards.
  • Strong attention to detail.
  • Proficient in MS Word and MS Excel.
  • Excellent communication skills.
  • Ability to handle many tasks with limited direction.
  • Ability to deliver results is a must.

Only local candidates will be considered.

If you are interested in learning more about current opportunities, contact us directly at [email protected]

 

ICQ Consultants continues to expand, hiring for QC Lab Validation specialist in Boston MA.

ICQ Consultants is working to support current and future projects in Boston, Massachusetts.  If you are considering a career change, we would love to hear from you.  ICQ is actively recruiting highly motivated professionals to join our team.

ICQ offers some of the most competitive benefits and wages in our segment of service providers which include the following:

    • Tufts Health Insurance, Delta Dental  – Paid 100% by ICQ, no employee premium.
    • Paid time off for Holidays, Sick Time and Vacation
    • 401K with a 100% match up to 4%
    • Short term / Long Term Disability – Paid 100% by ICQ
    • Life insurance – Paid 100% by ICQ
    • Reimbursed Project Specific Travel & Business Expenses 

EDUCATION/EXPERIENCE REQUIREMENTS

  • BS/BA degree in Biology, Biochemistry, Chemistry, Engineering or related experience in FDA-regulated industries working in QC, Manufacturing, Engineering, QA and/or Validation.
  • Experience or a demonstrated ability to perform the responsibilities of the position in leading, planning, and execution of projects involving one or more of the following:
    • 3 to 5 years QC Lab Validation Experience.

RESPONSIBILITIES

  • Develop and execute validation plans, test plans, validation protocols, and procedures.
  • Operates analytical instrumentation (i.e. HPLC, UPLC, GC, UV-vis, FTIR, laser diffraction, KF).
  • Participates in Laboratory and/or Quality Investigations.
  • Monitors equipment and instrumentation used on a daily basis to ensure proper operation and calibration.
  • Work as a leader, part of validation team, or independently to develop protocols and procedures, execute same including test functions, sampling, and calibration.
  • Communication with management, clients, and project team members.
  • Participate in training to ensure continued accreditation.
  • Other tasks as required by department management.

DESIRED SKILLS AND EXPERIENCE

  • Extensive experience with executing QC test methods, generating associated data packages, auditing data packages generated by others, troubleshooting instrumentation, trending data and statistical analyses required.
  • QC Lab Commissioning/Qualification/Validation
  • Strong Attention to Detail
  • Proficient in MS Word and MS Excel
  • Excellent Communication Skills
  • Ability to handle many tasks with limited direction
  • Ability to deliver results is a must

Only local candidates will be considered.

If you are interested in learning more about current opportunities, contact us directly at [email protected]

 

ICQ Consultants continues to expand, hiring for several new positions North of Boston MA.

ICQ Consultants is working to support current and future CQV projects in Northern Massachusetts.  If you are considering a career change, we would love to hear from you.  ICQ is actively recruiting highly motivated professionals to join our team.  ICQ has a blend of senior, mid, and entry-level positions available, focused on Quality, Compliance, Validation, and Project Management.

ICQ offers some of the most competitive benefits and wages in our segment of service providers which include the following:

    • Tufts Health Insurance, Delta Dental  – Paid 100% by ICQ, no employee premium.
    • Paid time off for Holidays, Sick Time and Vacation
    • 401K with a 100% match up to 4%
    • Short term / Long Term Disability – Paid 100% by ICQ
    • Life insurance – Paid 100% by ICQ

EDUCATION/EXPERIENCE REQUIREMENTS

  • BS/BA degree in Biology, Biochemistry, Chemistry, Engineering or related experience in FDA-regulated industries working in QC, Manufacturing, Engineering, QA and/or Validation.
  • Experience or a demonstrated ability to perform the responsibilities of the position in leading, planning, and execution of projects involving one or more of the following:
    • 3 to 5 years QC Lab Validation Experience.
    • 2 to 5 years Computer System Validation (Process Automation)
    • 2 to 5 years Commissioning, Qualification and Validation of Utilities, Facilities, Processes and Process Equipment

RESPONSIBILITIES

  • Develop and execute validation plans, test plans, validation protocols, and procedures.
  • Customarily and regularly exercises discretionary powers and independent judgment in performing the job.
  • Work as a leader, part of validation team, or independently to develop protocols and procedures, execute same including test functions, sampling, and calibration.
  • Communication with management, clients, and project team members.
  • Participate in training to ensure continued accreditation.
  • Other tasks as required by department management.

DESIRED SKILLS AND EXPERIENCE

  • QC Lab Commissioning/Qualification/Validation
  • Process Validation – General Principles and Practices
  • Computer System Validation (Automation – Delta V)
  • Commissioning, Qualification and Validation Generalist (Facilities, Utilities, Process Equipment etc.)
  • Strong Attention to Detail
  • Proficient in MS Word and MS Excel
  • Excellent Communication Skills
  • Ability to handle many tasks with limited direction
  • Ability to deliver results is a must

Only local candidates will be considered.

If you are interested in learning more about current opportunities, contact us directly at [email protected]

 

ICQ will be attending the PDA New England Chapter Dinner Event and Facility Tour.

dinner meeting.pngPlease join ICQ for the next New England PDA Dinner Meeting.  The meeting “Future Trends in Manufacturing” with Venkatesh Natarajan and Aaron Noyes will be held on Wednesday, March 14th at Millipore Sigma in Burlington MA.

NEPDA is offering an opportunity to visit MilliporeSigma’s new, state of the art M LabTM Collaboration Center in Burlington, MA. Inside the M LabTM, you can see pilot and process development labs containing biomanufacturing equipment used in multiple unit operations including upstream single-use bioreactors and clarification tools as well as downstream chromatographic purification and tangential flow concentration systems. The M LabTM Collaboration Center is a place where visitors have the freedom to explore applications and run experiments in an innovative, non-GMP environment.

ICQ will be a gold sponsor and we would love to connect with you at the event!

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Be part of an extraordinary team. ICQ is recruiting Process Validation Engineers in the Greater Boston Area.

If you are considering a career change, we would love to hear from you.  ICQ is actively recruiting highly motivated professionals to join our team.  We currently have opportunities available in Greater Boston.

ICQ offers some of the most competitive benefits and wages in our segment of service providers which include the following:

    • Short term / Long Term Disability – Paid 100% by ICQ
    • Life insurance – Paid 100% by ICQ
    • Tufts Health Insurance, Dental and Vision Plan – Paid 100% by ICQ
    • Paid time off for Holidays, Sick Time and Vacation
    • 401K with a 100% match to the first 4%

Positions report to the assigned manager and applicants are responsible for developing and executing protocols, including test functions, calibration, and sampling.  Must maintain compliance with the company’s Standard Operating Procedures and Policies.

EDUCATION/EXPERIENCE REQUIREMENTS

  • BS/BA degree in Biology, Biochemistry, Chemistry, Engineering or related experience in FDA-regulated industries working in QC, Manufacturing, Engineering, QA and/or Validation.
  • Experience or a demonstrated ability to perform the responsibilities of the position in leading, planning, and execution of projects involving one or more of the following:
    • 3 to 5 years QC Lab Validation Experience.
    • 2 to 5 years Computer System Validation (Process Automation)
    • 2 to 5 years Commissioning, Qualification and Validation of Utilities, Facilities, Processes and Process Equipment

RESPONSIBILITIES

  • Develop and execute validation plans, test plans, validation protocols, and procedures.
  • Customarily and regularly exercises discretionary powers and independent judgment in performing the job.
  • Work as a leader, part of validation team, or independently to develop protocols and procedures, execute same including test functions, sampling, and calibration.
  • Communication with management, clients, and project team members.
  • Participate in training to ensure continued accreditation.
  • Other tasks as required by department management.
  • Travel may be required.

DESIRED SKILLS AND EXPERIENCE

  • QC Lab Commissioning/Qualification/Validation
  • Process Validation – General Principles and Practices
  • Computer System Validation (Automation – Delta V)
  • Commissioning, Qualification and Validation Generalist (Facilities, Utilities, Process Equipment etc.)
  • Strong Attention to Detail
  • Proficient in MS Word and MS Excel
  • Excellent Communication Skills
  • Ability to handle many tasks with limited direction
  • Ability to deliver results is a must

Only local candidates will be considered.

If you are interested in learning more about current opportunities, contact us directly at [email protected]

 

If you’re looking to join a winning team, check us out, we are hiring. ICQ is recruiting Process Engineers in Trenton, NJ.

If you are considering a career change, we would love to hear from you.  ICQ is actively recruiting highly motivated professionals to join our team.  We currently have opportunities available in Trenton, NJ.

ICQ offers some of the most competitive benefits and wages in our segment of service providers which include the following:

    • Short term / Long Term Disability – Paid 100% by ICQ
    • Life insurance – Paid 100% by ICQ
    • Tufts Health Insurance, Dental and Vision Plan – Paid 100% by ICQ
    • Paid time off for Holidays, Sick Time and Vacation
    • 401K with a 100% match to the first 4%

Positions report to the assigned manager and applicants are responsible for developing and executing protocols, including test functions, calibration, and sampling.  Must maintain compliance with the company’s Standard Operating Procedures and Policies.

EDUCATION/EXPERIENCE REQUIREMENTS

  • BS/BA degree in Biology, Biochemistry, Chemistry, Engineering or related experience in FDA-regulated industries working in QC, Manufacturing, Engineering, QA and/or Validation.
  • Experience or a demonstrated ability to perform the responsibilities of the position in leading, planning, and execution of projects involving in one or more of the following:
    • 3 to 5 years QC Lab Validation Experience.
    • 2 to 5 years Process Manufacturing Experience.
    • 2 to 5 years Commissioning, Qualification and Validation of Utilities, Facilities, Processes and Process Equipment

RESPONSIBILITIES

  • Develop and execute validation plans, test plans, validation protocols, and procedures.
  • Customarily and regularly exercises discretionary powers and independent judgment in performing the job.
  • Work as a leader, part of validation team, or independently to develop protocols and procedures, execute same including test functions, sampling, and calibration.
  • Communication with management, clients, and project team members.
  • Participate in training to ensure continued accreditation.
  • Other tasks as required by department management.
  • Travel may be required.

DESIRED SKILLS AND EXPERIENCE

  • QC Lab Commissioning/Qualification/Validation
  • Computer System Validation (Automation – Delta V)
  • Commissioning, Qualification and Validation Generalist (Facilities, Utilities, Process Equipment etc.)
  • Strong Attention to Detail
  • Proficient in MS Word and MS Excel
  • Excellent Communication Skills
  • Ability to handle many tasks with limited direction
  • Ability to deliver results is a must

Only local candidates will be considered.

If you are interested in learning more about current opportunities, contact us directly at [email protected]