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: Validation Compliance Coordinator
Location: Texas
Provide computer system validation support for a leading contract development and manufacturing organization (CDMO) specializing in the production of biologics and advanced therapies. We are seeking a flexible and adaptable Validation Engineer to represent our team in Texas. In this role, you will be responsible for the validation strategy and SDLC documentation for various systems within the life sciences manufacturing environment.
Overview: The Validation Compliance Coordinator oversees validation deviations, CAPAs, change controls, and supports various validation activities.
Key Responsibilities:
- Coordinate and close validation deviations, CAPAs, and change controls.
- Assist with internal/external audits and prepare necessary documentation.
- Lead investigations into deviations and root causes.
- Manage equipment maintenance and calibration schedules.
- Act as point of contact for inspections and ensure compliance metrics are maintained.
Skills & Qualifications:
- Strong organizational, communication, and analytical skills.
- Experience in pharmaceutical/regulated industries, particularly in Quality Assurance.
- Bachelor’s degree in Engineering/Life Sciences or equivalent experience.
- Ability to work independently, multitask, and adapt to flexible work hours.
Physical Requirements:
- Prolonged standing, occasional lifting (up to 50 lbs), and manual dexterity. Attendance is mandatory.
Joining Valspec as a Validation Engineer (CSV) will provide you with an opportunity to make a significant impact in the validation and CSV processes for cutting-edge life sciences manufacturing systems. If you are a highly motivated and detail-oriented professional with a passion for ensuring compliance and data integrity, we encourage you to apply.
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.
What We Do
Valspec is the leading provider of computer system validation and system life cycle (SLC) services including the testing, commissioning and qualification of manufacturing automation and IT systems. Valspec was established with a mission to meet the wide spectrum of services that help our clients meet their goals. Our proven history in plant automation and engineering services has allowed us to branch out and be highly effective in meeting a variety of project and resource needs.
We look for passionate engineers like yourself who are looking to:
•Be an innovator
•Work with the best and brightest
•Build the career you want
•Work for a company you can be proud of
Many of the projects that we work on assure that life-changing drugs are available to those who need them. Other projects have a goal of streamlining production to meet demand at a lower cost so that the drug companies have the means to discover new life saving therapies.
