Verista, Inc.
6242 - Upstream Principal CQV Engineer / Lead Validation Engineer
Holly Springs, NC · Principal
Sponsorship not specified$108k-$168kDetected 62 days ago
GMPLeadershipCommunication
About the role
- Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
- Our talented and dedicated professionals are committed to making an impact every day.
- The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice.
Responsibilities
- Serve as the commissioning and qualification lead for Upstream systems (responsibilities described below).
- Gain a thorough understanding of system design by reviewing engineering documentation, P&IDs, and design specifications.
- Develop User Requirement Specifications (URS) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
- Create Commissioning Test Plans that translate design intent into testable steps.
- Develop Installation, Operational, and Qualification (IOQ) protocols.
- Take custody of the system post-construction and maintain ownership through C&Q completion.
- Perform Lockout/Tagout (LOTO) for system safety.
- C&Q Lead Responsibilities
- Engage with design engineers and SMEs to clarify system intent and operational requirements.
- Collaborate with SMEs to ensure system requirements are accurately reflected in test plans.
Requirements
- Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical discipline
- 10+ years of role specific experience
- Experience supporting CQV activities in GMP-regulated pharmaceutical or biotechnology environments
- Hands-on experience with downstream bioprocess equipment and purification systems
- Strong understanding of validation lifecycle documentation (IQ/OQ/PQ, protocols, reports)
- Ability to work independently while collaborating with cross-functional teams
- Experience with digital validation systems such as Kneat
- Experience supporting FAT/SAT, commissioning, and equipment startup
- Familiarity with risk-based validation approaches
- Experience in biologics manufacturing or monoclonal antibody production environments
Compensation
- For US geography, the salary range for this position is shown below.
Benefits
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- Tuition Reimbursement
- Paid Parental Leave and Bereavement
Company info
- 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
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This listing is sourced directly from Verista, Inc.'s careers page and normalized into a canonical job model.