Equipment Validation Engineer

Responsibilities

• Lead and execute CQV activities for GMP equipment including:
• Autoclaves
• CIP/SIP systems
• Bioreactors
• Incubators
• Freezers
• Refrigerators
• Centrifuges
• Washers
• Controlled temperature units
• Environmental chambers
• HVAC systems
• Clean steam generators
• WFI systems
• Process tanks
• Utility systems (compressed air, nitrogen, etc.)
• Develop and review validation documentation including URS, DQ, IQ, OQ, and PQ protocols and reports.
• Perform risk assessments and impact analyses to support validation strategy.
• Coordinate with client engineering, automation, and quality teams to ensure alignment on project goals and timelines.
• Troubleshoot and resolve equipment and process issues during commissioning and qualification phases.
• Maintain compliance with cGMP, FDA, and other applicable regulatory requirements.
• Provide timely updates and communicate effectively with client stakeholders.

Requirements

• Bachelor's degree in engineering, Life Sciences, or related field.
• 3+ years of experience in CQV within a GMP-regulated environment.
• Strong understanding of validation lifecycle and regulatory expectations.
• Experience with automated systems and controls integration is a plus.
• Excellent organizational and communication skills.
• Ability to work independently and manage multiple priorities.
• 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. Job Title: GMP Equipment Validation Engineer - CQV Position Overview: We are seeking a highly motivated and detail-oriented GMP Equipment Validation Engineer to support Commissioning, Qualification, and Validation (CQV) activities for a range of manufacturing and utility equipment at a client site in Swiftwater, PA. This role is ideal for someone who thrives in a dynamic environment, can work independently, and is confident interfacing directly with client teams. Our CQV team collaborates closely with the client across multiple facets of controls and automation, ensuring seamless integration and compliance with regulatory standards. The ideal candidate will bring strong technical expertise, excellent communication skills, and a proactive approach to problem-solving. The ideal candidate has experience leading the equipment CQV efforts of a team that also includes computer system validation engineers and specialists.

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