Senior CQV Engineer Cleaning Development- 3784SS

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.

This role will be on site Berkley, CA.

Must be present to support on-site execution and flexibility in working hours (i.e. Support execution during non-standard business hours).

Typical Project Accountabilities Include:

• Provide technical CQV (commissioning, qualification, and verification) expertise on 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.
• Review past validations, write and execute protocols, as well as author reports on the executed work. Protocol to be executed and summarized in report include but may not be limited to the following rFVIIII Cleaning Revalidation: rFVIII-PF UF/DF Skid
• Protocol to be written, executed and summarized in report include but may not be limited to the following rFVIIII Cleaning Validation: will include writing executing and summarizing reports including but may not be limited to the following CCTC Cleaning Development / Validation:o Coupon Studyo Swab Recoveryo Cycle Developmento Small Parts
• Verify system drawings including ability to review and as-build P&IDs and I&C drawings.
• 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 scop.

Requirements

• A minimum of a bachelor’s degree in an Engineering or Scientific degree and/or equivalent experience.

• 7+ years’ experience in GMP regulated environment.
• 7+ Pharma or Biological Experience
• Cleaning Validation expertise, with familiarity with UF/DF systems as well as experience on coupon study and swab recovery.
• Proficient with Valgenesis preferred.
  
• 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
• Must be present to support on-site execution and flexibility in working hours (i.e. Support execution during non-standard business hours).

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 Holi