Cleaning Validation Specialist

Validation & Engineering Group; Wade Hampton (SC); Presencial; USD 90.000 - 125.000; Tempo integral

Resumo da vaga

Pinnaql is seeking a Cleaning Validation Specialist to support full lifecycle cleaning validation activities at a regulated manufacturing site in Greenville, SC. The role emphasizes technical ownership and hands-on execution, from strategy through final report, while performing sampling aligned with production schedules.

The ideal candidate will independently lead cleaning validation efforts, possess strong GMP knowledge, and have experience with swab and rinse sampling, CIP systems, and Kneat.

Qualificações

• Bachelor’s degree in Engineering, Chemistry, Biology, or related science.
• 5+ years of cleaning validation experience in regulated environments.
• Experience with full lifecycle: strategy, protocol development, execution, reporting.
• Hands-on sampling using swab and rinse.
• Familiar with GMP and FDA/EU guidelines.
• Authorized to work in the United States without visa sponsorship.

Responsabilidades

• Develop cleaning validation strategies, master plans, and validation plans.
• Establish residue acceptance limits (MACO, HBEL/PDE, cleaning agent limits).
• Author cleaning validation protocols and reports.
• Execute cleaning validation protocols (swab, rinse, visual inspection).
• Coordinate sampling and testing with laboratories.
• Lead or support deviation investigations and CAPA.
• Train operators on cleaning procedures and sampling techniques.
• Provide guidance on cleaning processes (CIP/COP, solvents, cleaning agents).
• Collaborate with Quality, Manufacturing, and Laboratory teams for timely execution.

Conhecimentos

Cleaning validation

GMP knowledge

Technical writing

Independent work

Sampling techniques

CAPA investigations

Team collaboration

Formação

Bachelor’s degree in Engineering, Chemistry, Biology, or related science

Ferramentas

Kneat

CIP systems

Descrição da vaga

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are seeking a talented, dedicated individual committed to work under the highest ethical standards for the following position:

• Cleaning Validation Specialist

Description

We are seeking a Cleaning Validation Specialist to support full lifecycle cleaning validation activities at a regulated manufacturing site in Greenville, SC. This role is part of a broader initiative to strengthen cleaning validation practices and ensure compliance with current regulatory and site standards.

The position requires both technical ownership and hands on execution. The ideal candidate can independently lead cleaning validation efforts, from strategy through final report, while also performing sampling and execution activities in alignment with production schedules.

Key Responsibilities

• Develop cleaning validation strategies, master plans, and validation plans, including product and equipment grouping and worst case selection
• Establish or support residue acceptance limits (MACO, HBEL/PDE, and cleaning agent limits)
• Author cleaning validation protocols, reports, and supporting risk assessments
• Execute cleaning validation protocols, including swab, rinse, and visual inspection
• Coordinate sampling and testing activities with the laboratories
• Lead or support deviation investigations, root cause analysis, and CAPA related to cleaning validation
• Train operators and staff on cleaning procedures, sampling techniques, and protocol execution
• Provide technical guidance on cleaning processes, including cleaning agents, solvents, CIP and COP, and manual cleaning methods
• Collaborate with Quality, Manufacturing, and Laboratory teams to ensure successful and timely execution
• Support other Commissioning, Qualification, and Validation activities as needed based on project demands

Required Qualifications

• Bachelor’s degree in Engineering, Chemistry, Biology, or a related science
• 5+ years of cleaning validation experience in a regulated environment (pharmaceutical, biotech, or medical device)
• Proven experience with the full cleaning validation lifecycle: strategy, protocol development, execution, and reporting
• Hands on experience with swab and rinse sampling techniques
• Strong knowledge of GMP requirements and applicable guidance (FDA, EU Annex 15, ICH Q7 and Q9)
• Excellent technical writing skillsAbility to work independently with minimal supervision
• Experience in sterile or ophthalmic manufacturing
• Experience with CIP systems and automated cleaning processes
• Experience with electronic validation systems (for example, Kneat)
• Candidates must be authorized to work for any employer in the United States without visa sponsorship, we are not able to sponsor a visa or work on a C2C basis for this opportunity.

Work Requirements

• On site position in a manufacturing environment
• Flexibility to work early, late, off shift, and weekend hours to support sampling based on production schedules
• Ability and willingness to enter confined spaces, including tanks and similar equipment, to perform inspections, measurements, and sampling in compliance with site safety procedures

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.