Senior Validation Engineer

BioTalent; Portsmouth (NH); On-site; USD 120,000 - 180,000; Full time

Job summary

BioTalent in Portsmouth, NH seeks a highly experienced Cleaning Validation & Equipment Validation Engineer to build core validation programs from the ground up in a GMP biopharma setting. You will author SOPs, create validation documentation, and drive sustainable processes with minimal direction.

The role requires 8+ years in pharmaceutical validation, hands-on experience with cleaning validation, CIP/COP/SIP systems, IQ/OQ/PQ, and direct Kneat usage.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 8+ years of pharmaceutical, biotechnology, or regulated manufacturing validation experience.
• Demonstrated experience establishing cleaning validation programs from the ground up.
• Direct experience with Kneat is required.

Responsibilities

• Design, develop, and implement cleaning validation and equipment validation programs with limited oversight.
• Author SOPs, validation plans, protocols, and reports.
• Lead qualification and validation activities for autoclaves, parts washers, and cold storage equipment.
• Develop temperature mapping procedures and support mapping studies.
• Drive validation activities related to equipment changes, process improvements, deviations, CAPAs, and change controls.

Skills

Engineering

GMP

SOP Writing

Validation

Independent work

Education

Bachelor's degree in Engineering/Life Sciences

Tools

Kneat

Ellab

Job description

Position Overview

We are seeking a highly experienced Cleaning Validation & Equipment Validation Engineer to establish and build core validation programs from the ground up within a GMP-regulated biopharmaceutical manufacturing environment. This is not a maintenance role supporting an existing validation program. The successful candidate will be responsible for developing strategies, authoring SOPs, creating validation documentation, and implementing sustainable processes with minimal direction.

Many validation professionals have experience executing protocols that have already been developed. This position requires someone who has successfully built cleaning validation and equipment validation programs from scratch and can serve as the site's subject matter expert.

Key Responsibilities

• Design, develop, and implement cleaning validation and equipment validation programs with limited oversight.
• Author SOPs, validation plans, protocols, reports, and lifecycle documentation related to:
• Cleaning Validation
• Equipment Qualification
• Temperature Mapping
• Equipment Requalification Programs
• Build and maintain equipment requalification programs within Kneat.
• Serve as the subject matter expert for cleaning validation activities, including:
• Clean-In-Place (CIP)
• Clean-Out-of-Place (COP)
• Steam-In-Place (SIP)
• Support cleaning validation efforts primarily focused on media hold and media fill processes, as approximately 95% of manufacturing equipment is single-use.
• Lead qualification and validation activities for:
• Autoclaves
• Parts Washers
• Cold Storage Equipment
• Execute and approve IQ/OQ activities and develop PQ strategies where required.
• Develop temperature mapping procedures and support mapping studies.
• Drive validation activities associated with equipment changes, process improvements, deviations, CAPAs, and change controls.
• Ensure equipment remains in a validated state through ongoing validation maintenance and periodic requalification activities.
• Partner with Manufacturing, Engineering, Quality, and QC teams to provide validation expertise and support.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 8+ years of pharmaceutical, biotechnology, or regulated manufacturing validation experience.
• Demonstrated experience establishing cleaning validation programs from the ground up.
• Extensive hands-on experience with:
• Cleaning Validation
• CIP, COP, and SIP Systems
• Equipment Qualification (IQ/OQ/PQ)
• GMP Manufacturing Environments
• SOP Development and Technical Writing
• Direct experience with Kneat is required.
• Strong experience authoring SOPs for cleaning validation, equipment qualification, and temperature mapping activities.
• Proven ability to work independently and build compliant validation programs with minimal guidance.

Preferred Qualifications

• Experience with Ellab temperature mapping systems.
• Experience qualifying autoclaves, parts washers, controlled room-temperature storage, and cold-storage equipment.
• Experience working in biologics, cell therapy, gene therapy, or sterile manufacturing environments.
• Familiarity with TrackWise, electronic quality systems, and validation lifecycle management.

Ideal Candidate

The ideal candidate is a senior validation professional who has personally developed cleaning validation and equipment qualification programs rather than simply executing existing protocols. They will possess deep expertise in cleaning validation strategy, SOP development, temperature mapping, and GMP compliance, and will be comfortable acting as the technical lead responsible for building and sustaining validation programs from the ground up.