Life Sciences Manufacturing Consultant – Validation Lifecycle & Requalification

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.