Job ID: 2015
Role Overview
As we move into 2026, the biopharmaceutical landscape continues to evolve with a heavy emphasis on automated, high-throughput manufacturing. We are seeking a Senior Biopharmaceutical Validation Engineer for a critical 12-month contract in the Northern Minneapolis metro area. This role is pivotal in ensuring that our client’s manufacturing equipment and integrated GMP systems meet the highest standards of quality and regulatory compliance. The successful candidate will lead Commissioning, Qualification, and Validation (CQV) efforts for both multi-use and single-use manufacturing technologies, ensuring a seamless transition from engineering to production.
Key Responsibilities
- Lead the lifecycle validation process by authoring, reviewing, and executing complex commissioning and qualification protocols (IQ/OQ/PQ).
- Focus on the CQV of advanced manufacturing equipment including Bioreactors, Chromatography systems, and Tangential Flow Filtration (TFF) units.
- Collaborate extensively with automation and engineering teams to synchronize physical equipment with automated control systems, ensuring full compliance with site SOPs.
- Develop and manage technical documentation, including Validation Summary Reports (VSR), Deviation Reports, and Traceability Matrices.
- Implement risk-based validation strategies utilizing ASTM E2500 frameworks to streamline qualification activities without compromising quality or safety.
- Oversee Computer Systems Validation (CSV) for integrated GMP systems, ensuring data integrity and alignment with 21 CFR Part 11 requirements.
- Manage deviations and CAPAs related to validation activities, providing technical expertise to resolve complex engineering challenges.
Technical Requirements and Qualifications
- A minimum of 6+ years of dedicated CQV and CSV experience within the Life Sciences or Biopharmaceutical industry.
- Subject Matter Expertise (SME) in biologics manufacturing processes, specifically downstream and upstream operations.
- Advanced proficiency with paperless validation platforms, with a strong preference for candidates experienced in KNEAT.
- Hands-on experience with automation platforms such as Emerson DeltaV or Symphony Plus.
- Deep understanding of Manufacturing Execution Systems (MES), Building Automation Systems (BAS), and their integration into the validated state.
- Comprehensive knowledge of global regulatory standards, including 21 CFR Part 11 and ALCOA+ data integrity principles.
- Proven ability to work autonomously in a fast-paced, high-stakes manufacturing environment, driving projects to completion on schedule.
Project Environment and Impact
This contract offers the opportunity to work at the forefront of biopharmaceutical innovation. The Northern Minneapolis site is a hub for advanced biologics, and your work will directly impact the delivery of life-saving therapies. You will be expected to maintain a high level of professional autonomy, managing multiple workstreams and interacting with cross-functional stakeholders from Quality Assurance, Engineering, and Operations. The project duration is estimated at 12+ months, starting in March 2025, with potential for extension as the facility expands its manufacturing capabilities.
Special Requirements
Local candidates only; Interview mode: Skype; 12+ months contract duration; Domain: Life Sciences/Biopharma.
Compensation & Location
Salary: $155,000 – $205,000 per year (Estimated)
Location: Minneapolis, MN
Recruiter / Company – Contact Information
Recruiter / Employer: Vyze Inc
Email: pbaghel@vyzeinc.com
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