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: Factory Acceptance Test (FAT) Engineer
Location:
Midwest U.S. (Travel Required) - 2-3 days per week
Job Summary:
We are seeking an experienced Factory Acceptance Test (FAT) Engineer to join our team. The ideal candidate will have a strong background in performing FATs on equipment in GMP and regulated environments. This role requires the ability to travel to the Midwest U.S. and collaborate with various teams to ensure equipment meets all necessary standards and specifications about 2-3 days per week.
Key Responsibilities:
- Perform Factory Acceptance Tests (FAT) on equipment to ensure compliance with GMP and regulatory standards.
- Develop and execute FAT protocols, including test plans, procedures, and reports.
- Collaborate with cross-functional teams, including engineering, quality assurance, and manufacturing, to resolve any issues identified during FAT.
- Ensure all equipment meets the required specifications and standards before shipment to the customer site.
- Document and report any deviations or non-conformances identified during FAT and work with relevant teams to implement corrective actions.
- Provide technical support and guidance to customers during FAT and address any questions or concerns.
- Maintain up-to-date knowledge of GMP regulations and industry best practices related to FAT.
Qualifications:
- Strong understanding of engineering principles and Facilities, Utilities, Systems, and Equipment systems.
- Expertise in Classified Clean Rooms, Sterilization Equipment, and Temperature Controlled Units
- Knowledge of ISPE Baseline 5, Vol. 2, and FDA regulations.
- Experience performing FATs on equipment in GMP and regulated environments.
- Understanding of GMP regulations and industry standards.
- Ability to travel to the Midwest U.S. as required.
Pay:
- $100/Hr. but may not reach 40 hours per week sometimes.
Opportunity:
This is a fantastic opportunity for someone with a strong Factory Acceptance Testing background who can travel to the Midwest and work onsite. You'll be part of a cutting-edge life sciences team, contributing to impactful projects and advancing your career in a dynamic setting.
Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, profit sharing, tuition reimbursement, and other unique incentives.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.Valspec is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.
