Job Description
Job description This a contract position with the client for a 12 month contract likely to be extended as required. Client is a multinational CDMO at the forefront of cutting edge innovation in the biotech space. What You Will Do Lead efforts between internal customers and CSV to ensure assigned activities are prioritized, communicated in an effective and timely manner, and completed on time. Accountable for maintaining full knowledge company policies/procedures, 21 CFR Part 11, Data Integrity, ICH Q7A requirements and GAMP and the underlying principles of each. Perform all aspects of Quality Systems Management (QSM) processes (Change Control, Deviation, Corrective and Preventable Actions) as well as Validation Maintenance of computerized systems. Own, revise and maintain computer systems validation SOPs (Standard Operations Procedures). Function as CSV SME in Inspections and Audits. What We Are Looking For Bachelor’s degree required, preferred in computer science, engineering, or other sciences. Minimum of 5 years of experience working with automation and/or computerized system validations. Minimum 2 years’ experience with Controls Automation, Process Control Systems, Distributed Systems, Manufacturing Execution Systems (MES) required, DeltaV preferred. Prior experience leading or managing projects beneficial. CAPAs and deviations experience desired. Biotech/Pharma/Medical Device/Medical or biologics industry experience required. Ability to work independently and meet deadlines successfully. **Sponsorship not available for this role Job Type: Contract Pay: From $75.00 per hour Benefits 401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off Relocation assistance Vision insurance Application Question(s): Are you able to work without sponsorship (H1B, OPT, CPT etc.)? Work Location: In person