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.
Equipment Validation Engineer
Location: Texas
Summary:
Join a major life sciences organization in Texas as a Sr. Validation Engineer. In this onsite role, you’ll independently draft and execute validation protocols for Facilities, Utilities, Systems, and Equipment, and prepare final reports.
Key Responsibilities:
- Create and execute Validation Project Plans (VPPs), System Impact Assessments (SIAs), Risk Assessments, and validation deliverables for Facilities, Utilities, Systems, and Equipment systems.
- Plan and coordinate validation activities with cross-functional teams.
- Lead mid-size validation projects and mentor junior engineers.
- Review and provide feedback on System Delivery Life Cycle (SDLC) deliverables.
- Develop and update SOPs, forms, and templates.
- Ensure compliance with regulatory and industry standards.
Required Skills:
- 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.
- Excellent communication skills.
- Proficiency in Microsoft Office.
- Ability to work independently in a fast-paced environment.
Opportunity:
This is a fantastic opportunity for someone with a strong validation background who can travel to Texas 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.
