Validation Specialist - Single Use Systems

The Validation Specialist – Single-Use Systems (SUS) is responsible for supporting qualification, validation, and lifecycle management activities associated with single-use technologies utilized in pharmaceutical and biopharmaceutical manufacturing operations. This role supports Manufacturing Science and Technology (MSAT) initiatives and ensures SUS equipment, assemblies, and processes comply with GMP, regulatory, and company requirements while supporting safe, compliant, and efficient manufacturing operations.

• Execute qualification and validation activities for Single-Use Systems (SUS) utilized in pharmaceutical and biopharmaceutical manufacturing environments.
• Support MSAT initiatives related to process optimization, manufacturing support, technology transfer, process validation, and continuous improvement activities.
• Single-use bioreactors
• Mixing systems
• Disposable bags
• Tubing assemblies
• Filters
• Connectors
• Manifolds
• Process transfer systems
• Develop, review, and execute validation documentation including:
• Validation plans
• Design Summary Report (DSR)
• IQ/OQ/PQ protocols
• User Requirement Specification (URS)
• Leveraging Report
• Traceability matrices
• Summary reports
• Support commissioning, startup, and qualification activities for new manufacturing systems and equipment.
• Review vendor documentation including Certificates of Conformance (COC), sterilization certificates, extractables and leachables reports, and material compatibility data.
• Collaborate with MSAT, Manufacturing, Engineering, Quality Assurance, Quality Control, and external vendors to support validation execution and issue resolution.
• Support deviation investigations, CAPAs, change controls, and non-conformance activities related to validation and SUS operations.
• Ensure compliance with FDA, EMA, cGMP, and internal validation procedures and standards.
• Maintain validation lifecycle documentation and support periodic review activities.
• Identify and support continuous improvement opportunities related to validation processes and single-use technologies.

• Bachelor’s degree in Engineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, Chemistry, or related technical discipline required.
• Advanced degree preferred but not required.

• Minimum of 5+ years of validation experience within pharmaceutical, biotechnology, medical device, or GMP-regulated manufacturing environments.
• Minimum 3+ years of experience supporting Single-Use Systems (SUS), bioprocess equipment, or sterile manufacturing operations preferred.
• Experience developing and executing IQ/OQ/PQ protocols and validation lifecycle activities required.
• Experience supporting MSAT functions within biologics, sterile, or pharmaceutical manufacturing environments preferred.