Senior Cleaning Validation & Equipment Validation Engineer

United Pharma; New Hampshire; On-site; USD 140,000 - 200,000; Full time

Job summary

United Pharma seeks a highly experienced Cleaning Validation & Equipment Validation Engineer to establish comprehensive validation programs in a GMP‑regulated biopharmaceutical setting. This role focuses on building programs from the ground up, authoring SOPs, and implementing sustainable validation processes with minimal supervision.

The candidate will lead cleaning validation, equipment qualification, temperature mapping, and requalification programs, with expertise in CIP, COP, SIP, and

Qualifications

• 8+ years in pharmaceutical/biotech validation.
• Experience building cleaning validation programs from scratch.
• Hands-on in Cleaning Validation, CIP/COP/SIP; IQ/OQ/PQ.
• Direct Kneat experience required; SOP development and technical writing.

Responsibilities

• Design, develop and implement cleaning validation and equipment validation programs with limited oversight.
• Author SOPs, validation plans, protocols, reports, and lifecycle documentation.
• Build and maintain equipment requalification programs (IQ/OQ/PQ).
• Lead validation activities for autoclaves, parts washers, cold storage, and other equipment.
• Drive CAPA, deviations, and change controls related to validation.

Skills

Cleaning validation

Equipment qualification

SOP development

Technical writing

GMP compliance

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

Kneat

Ellab

TrackWise

Job description

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.