CQV Engineer - Pharmaceutical Quality Systems
Swiftwater , PA
Posted 1 week ago
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Ask About our Hiring Bonus for Candidates with 2 or more years of Pharmaceutical Manufacturing Experience Hired between 10/1/2021 and 12/31/2021!
Who are we:
Looking for an exciting opportunity at a fast growing, employee-oriented company?Veristas 500+ experts team up with the worlds most recognizable brands in the life science industry to solve their business needs. Whether its compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.
Veristas experts include SMEs across the spectrum of pharma, medical devices and biotech industries. As a result, were uniquely capable of offering transformative, integrated solutions, new perspectives, and consistent results.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable our clients to improve the quality of patient healthcare worldwide. Our talented and dedicated professionals are committed to making an impact every day.
We deliver solutions that are right the first time.
Typical Project Accountabilities Include:
- Provide technical CQV (commissioning, qualification, and verification) expertise on large capital projects involving new or modified equipment, facilities, and utilities ensuring CQV aspects are delivered consistently and efficiently. Includes authoring and executing documents such as URS, System boundary definition, Risk Assessment, Traceability matrices, Design Qualification, Start Up and Debug documentation, commissioning documents, including FAT and SAT, IQ/OQ/PQ, Turnover documentation.
- Author and execute technical commissioning and qualification documentation for complex, automated equipment, and processes, in accordance with clients quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 210, 211 and 820 level standards which apply to the equipment and product being validated) and national/international standards.
- Verify system drawings including ability to review and as-build P&IDs and I&C drawings as well as verifying electrical schematics with electrical engineering support.
- Manage and work collaboratively with clients quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Maintain clear and detailed records of qualification and change control activities for future compliance audits.
- Project assignments will vary by customer requirements for specific defined deliverables based on project needs and scope
- This specific opportunity will be focused in the area of Quality system management for large scale capital projects.
- A minimum of a bachelors degree in an Engineering or Scientific degree
- 3+ years experience in GMP regulated environment
- Requires prior experience in pharmaceutical quality systems. This role will be responsible for execution of operational activities related to capital equipment projects with a workstream breakdown of key quality systems activities including Vendor Management, Batch Release, Deviation and Change Management, Validation and Qualification.
- Technical understanding and experience with automated equipment for manufacturing, device assembly, and packaging (PLCs, HMIs, PC based controls)
- Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls
- Intermediate to Expert (Senior and Lead) knowledge of FDA regulations, ISPE guidelines and ISO standards including Good Documentation Practice (GDP) in pharmaceutical environment
Because employees are the key to our success, Verista offers strong benefits and incentives including:
- Health, Dental, and Vision Insurance
- 401(k) Retirement Plan with a company match
- Paid Time Off Pay
- Tuition Reimbursement
- 9 Company Paid Holidays
- Paid Long Term & Short Term Disability Insurance
- Training and Development
- Paid Maternity Leave and Parental Leave
- Travel Bonus
- Employee Referral Program
- Tuition Reimbursement
- Marriage Leave
*Verista is an Equal Opportunity Employer