Job Posting: Automation Project Manager/Engineer, Greater Baltimore Area
Job Posting: Automation Project Manager/Engineer
Duration: 6 to 9 months, Initial Term
Positions: 1
Employment Type: ICQ W2
Location: Greater Baltimore Area
EDUCATION & EXPERIENCE REQUIREMENTS
B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries.
RESPONSIBILITIES
- Manage the automation & construction project scope including budgeting, project management, resource allocation, integration, validation, data migration, training, SOPs, IT standards and system infrastructure needs to ensure a successful deployment into production. Oversee documentation of system requirements, functional requirements, technical specifications, and testing protocols using industry standards and the latest GAMP guidelines.
- Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting schedule, budgetary and quality expectations of the client.
- Customarily and regularly exercises discretionary and independent judgment in performing the job.
- Participate in training to ensure continued accreditation.
- Maintain a safe working environment for self, team members and clients operational or administrative staff.
- Other tasks in alignment with your skills and competencies as required by the project, client and/or management.
REQUIRED EXPERIENCE
- Must have excellent organizational, verbal and written communication skills; with demonstrated ability to efficiently and effectively communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
- Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project (as needed).
- Must be a self-starter, detail oriented and able to work independently with minimal supervision.
- Excellent troubleshooting skills; ability to react quickly to understand and solve problems.
REQUIRED SKILLS
- 3 to 5 years of Commissioning, Qualification and/or Validation (CQV) with experience in Bio-process operations.
- Project management experience with business and systems analysis, 21 CFR Part 210, 211, 820 and 11, EudraLex Annex 11, ISO, and other GxP computer system validation (CSV), technical practice management, application development, and pharmaceutical clinical liaison.
- GxP experience in managing the analysis, implementation, and validation of hardware and software solutions for the life sciences industry.
- GxP experience in managing the analysis, implementation, and validation of hardware and software solutions for the life sciences industry.
- Experience writing protocols, performing execution for processes, equipment and utilities used in the Biotech or Pharmaceutical Industry.
- Manage stakeholder expectations, address user, functional, design requirements, and configuration specification; mitigate validation issues, quality on in the project. Employ industry best practices and processes.
Please note that only local candidates will be considered.
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