CQV Consultant

Responsibilities

• Execute CQV lifecycle activities including commissioning, IQ/OQ, and field verification
• Support startup and qualification of GMP manufacturing equipment and utility systems
• Author, review, and execute validation documentation and protocols
• Coordinate with engineering, operations, quality, automation, and project teams
• Support deviation investigations, change controls, and CAPA activities
• Ensure compliance with GMP, FDA, and regulatory requirements
• Participate in walkdowns, system turnover, and punch-list resolution
• Maintain accurate documentation in accordance with data integrity and quality standards

Requirements

• Prior CQV experience in pharmaceutical, biotech, or GMP-regulated manufacturing environments
• Strong knowledge of commissioning and qualification processes
• Experience supporting one or more of the following: Upstream, Downstream, CIP, PSE, or Clean Utilities systems
• Familiarity with GMP documentation practices and regulatory requirements
• Ability to work onsite in Holly Springs, NC on a full-time basis
• Strong communication and cross-functional collaboration skills
• Preferred Experience
• Large-scale biologics or vaccine manufacturing projects
• Startup or greenfield facility experience
• Experience with DeltaV, MES, or automated process systems
• Knowledge of clean utilities including WFI, clean steam, compressed gases, and purified water systems
• Why Join Valspec?
• Premium medical coverage
• 401(k) with company match
• Tuition reimbursement
• Unique performance incentives
• And more - all designed to support your growth, well-being, and future.
• Join a team where your contributions matter, your development is prioritized, and your success is shared.
• When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net. Any other domains are impersonations and should be ignored.
• Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.
• Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Benefits

Additional Information

Valspec-a global provider of system validation and lifecycle services-provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals. Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies. CQV Consultant - Upstream / Downstream / CIP / PSE / Clean Utilities Location: Holly Springs (100% Onsite) Type: Long-Term Contract Start Date: ASAP Overview We are seeking experienced CQV Consultants to support a major biopharmaceutical manufacturing project in Holly Springs, NC. This is a long-term onsite opportunity supporting commissioning, qualification, and validation activities across multiple process and utility systems in a GMP manufacturing environment. We are specifically looking for strong "A+" level consultants with hands-on pharmaceutical or biotech project experience supporting large-scale manufacturing operations. We are hiring CQV professionals with experience in one or more of the following areas: Upstream Processing Downstream Processing CIP (Clean-in-Place) Systems PSE (Process Support Equipment) Clean Utilities

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