6244 - CIP (Clean-in-Place) CQV Engineer / Lead Validation Engineer

Verista, Inc.•Apex, NC

10d•Onsite

About The Position

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. 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 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 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.

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

Responsibilities

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.
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.
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.
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.
Utilize electronic validation platforms (e.g., Kneat) to develop, manage, and execute validation documentation.
Ensure documentation integrity, traceability, and compliance within digital validation systems.