Life Sciences Manufacturing Consultant – Validation Lifecycle & Requalification

Job description

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. ## Life Sciences Manufacturing Consultant – Validation Lifecycle & Requalification **Southern California | Onsite | 12-Month Project | Start Date: February 2027** **Valspec | Life Sciences Commissioning, Qualification & Validation Experts** ### Help Support Critical GMP Manufacturing Operations Valspec is seeking an experienced **Life Sciences Manufacturing Consultant** to support validation lifecycle activities at a leading biopharmaceutical manufacturing facility in Southern California. This role will focus on maintaining the validated state of **GMP manufacturing equipment, facilities, utilities, and associated systems** through **Periodic Review, Lifecycle Maintenance, and Requalification** activities. This is an excellent opportunity for a validation professional who understands that qualification does not end after initial commissioning and enjoys working directly with Engineering, Manufacturing, Quality, and Validation teams to ensure systems remain compliant throughout their lifecycle. ### Key Responsibilities - Perform **Periodic Reviews** of GMP assets and validated systems. - Support **lifecycle maintenance** of equipment, facilities, utilities, and manufacturing systems. - Plan, coordinate, and execute **requalification activities** based on established schedules and risk assessments. - Review equipment history, deviations, change controls, maintenance activities, calibration records, and previous qualification documentation. - Determine whether systems remain in a validated state and identify required follow-up actions. - Develop and execute requalification protocols and supporting documentation. - Prepare Periodic Review reports, requalification reports, assessments, and validation documentation. - Evaluate changes to validated assets for potential qualification or validation impact. - Work closely with **Engineering, Facilities, Manufacturing, Quality, Maintenance, Calibration, and Validation** teams. - Ensure documentation and activities meet applicable **cGMP and site validation requirements**. - Help maintain accurate asset and validation lifecycle records. ### Required Experience **Must Have** - Experience in pharmaceutical, biotechnology, cell therapy, gene therapy, or other regulated life sciences manufacturing environments. - Hands-on experience with **Periodic Review, Requalification, or Validation Lifecycle Management**. - Experience maintaining the validated state of GMP equipment or systems. - Understanding of **IQ/OQ/PQ and equipment qualification principles**. - Experience reviewing validation documentation, deviations, change controls, maintenance records, and calibration history. - Strong understanding of **cGMP documentation requirements**. - Strong technical writing and documentation skills. - Ability to work onsite and coordinate activities across multiple functional groups. **Strongly Preferred** - Experience supporting **cell therapy, biologics, aseptic, or other highly regulated manufacturing operations**. - Experience with equipment and asset lifecycle programs. - Facility, utility, HVAC, cleanroom, or manufacturing equipment qualification experience. - Experience developing risk-based requalification strategies. - Familiarity with **ASTM E2500, risk-based validation, and modern CQV methodologies**. - Experience working within an established operating manufacturing facility rather than solely on greenfield CQV projects. ### What We're Looking For ✅ Strong **Periodic Review and requalification** experience ✅ Understanding of the complete **GMP asset lifecycle** ✅ Comfortable working onsite in an active manufacturing environment ✅ Strong technical writing and documentation skills ✅ Able to review asset history and determine validation impact ✅ Comfortable working across Validation, Quality, Engineering, Manufacturing, and Maintenance ✅ Self-starter who can manage multiple assets and lifecycle activities simultaneously ### About Valspec Valspec is a specialized Commissioning, Qualification, Validation, Automation, and Digital GxP consulting organization supporting leading pharmaceutical and biotechnology companies across North America. Since 1999, Valspec has delivered high-quality engineering and compliance solutions that help bring lifesaving therapies to market. Valspec is an ESOP company focused on technical excellence, integrity, and employee ownership. ### Project Details **Location:** Southern California **Work Arrangement:** Onsite **Project Duration:** 12 months **Anticipated Start:** February 2027 --- ## Compensation **Salary Range:** $110,000 - $120,000 annually *Salary range is an estimate for project-based employment and varies based on experience, qualifications, and employment type. Higher compensation may be available for highly qualified consultants, independent contractors, or short-term project assignments.* --- ### Ready to Make an Impact? Join Valspec and help support the facilities and manufacturing systems that deliver critical therapies to patients around the world. **Apply Today!** **Why Join Valspec?** At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation. We also offer a highly competitive benefits package, including: - 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. 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.