We are seeking a
CQV Engineer with hands-on experience supporting Clean-in-Place (CIP) systems within biopharmaceutical manufacturing environments. This role will focus on commissioning, qualification, and validation activities for
CIP systems and related process equipment, ensuring systems are designed, installed, tested, and qualified in compliance with
cGMP and regulatory expectations.
The ideal candidate will bring strong experience across the
CQV lifecycle, including authoring validation documentation, supporting commissioning activities, coordinating vendor testing, and ensuring systems achieve operational readiness. Experience working within
digital validation platforms such as Kneat is highly desirable.
This role requires someone who can
work independently while collaborating cross-functionally with engineering, automation, vendors, and quality teams to ensure successful project execution throughout the lifecycle of the system.
CIP (Clean-in-Place) CQV Engineer Responsibilities:Commissioning, Qualification & Validation- Support commissioning, qualification, and validation (CQV) activities for CIP systems and related process equipment.
- Author, review, and execute CQV lifecycle documentation including:
- Commissioning protocols
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Validation summary reports
- Ensure validation documentation complies with cGMP requirements and regulatory expectations.
- Participate in system impact assessments, risk assessments, and validation planning activities.
CIP System Support- Provide technical support for Clean-in-Place (CIP) systems and automated cleaning processes used in biopharmaceutical manufacturing.
- Support qualification of CIP skids, automated cleaning cycles, and associated process equipment.
- Verify cleaning cycle parameters including flow rates, temperatures, chemical concentrations, and cycle timing.
- Assist with troubleshooting and process verification during commissioning and qualification activities.
Vendor & Equipment Startup- Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new CIP equipment and systems.
- Coordinate with equipment vendors and system integrators to ensure systems are installed and functioning according to design specifications.
- Participate in equipment startup, commissioning, and operational testing activities.
Cross-Functional Collaboration- Collaborate with engineering, automation, quality assurance, and manufacturing teams to ensure successful project execution.
- Assist with deviation investigations, change control processes, and documentation updates.
- Ensure CQV activities align with project schedules and operational readiness milestones.
Digital Validation Systems- Utilize electronic validation platforms (e.g., Kneat) to develop, manage, and execute validation documentation.
- Ensure documentation integrity, traceability, and compliance within digital validation systems.
Requirements:- Bachelor's degree in Engineering, Biotechnology, Life Sciences, or a related technical discipline
- Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments
- Hands-on experience with CIP systems and automated cleaning processes
- Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ protocols and reports)
- Ability to work independently while coordinating with cross-functional project teams
- Strong technical documentation and communication skills
- Experience using digital validation platforms such as Kneat
- Experience supporting FAT/SAT, commissioning, and equipment startup
- Familiarity with automated process systems and PLC-based equipment
- Experience in biologics or large-scale biopharmaceutical manufacturing environments
- Onsite job requirement in Apex, NC
For US geography, the salary range for this position is shown below. 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. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.National (US) Range
$87,780-$136,225 USD
BenefitsWhy Choose Verista?
- High growth potential and fast-paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
