CQV Engineer 3030/31DB Remote - domestic and international travel

Verista’s 700 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise.

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 client’s 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 UNIQUE opportunity will be fully remote, but will have responsibility for supporting our client with CMOs in Philadelphia and Germany and European equipment vendors.

The selected candidate will use a web-based, cloud-based validation lifecycle management application for the development, review and approval of deliverables to include:

• C&Q process, schedule, draft and deliverables
• Guidance and education of partners
• Monitoring of process metrics
• Continuous Improvement
• Design Review
• Management of support staff as necessary

Requirements

• A minimum of a bachelor’s degree in an Engineering or Scientific degree
• 3+ years experience in Equipment and computer system validation
• Experience leading cross-functional CQV teams
• Demonstrated experience in creation and execution of validation deliverables.
• Prior experience with projects related to automated packaging equipment

Preferred:

• 3+ years’ experience in GMP regulated environment
• 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. Experience leading large complex projects in a cross-functional matrix environment preferred.
• Prior experience using digital (paperless) validation tools, such as Kneat.
• Intermediate to Expert (Senior and Lead) knowledge of FDA regulations, ISPE guidelines and ISO standards including Good Documentation Practice (GDP) in pharmaceutical environment
• ASTM-E2500

Benefits

Why Verista?

• High growth potential and fast paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company paid medical premiums.
• Company paid Life, Short-Term, and Long-Term Disability insurances
• Dental & Vision insurances
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays