Overview The
Staff Engineer - Process & Cleaning Validation position is an exciting opportunity to join PM Group's quickly growing Outsourced Technical Services(OTS) team near
Zebulon, NC. Outsourced Technical Services (OTS) is an integral part of PM Group's ability to support clients across the complete project life cycle. We have over 50 years' industry experience, strong technical knowledge and integrated resources. Clients look to us to provide experienced technical professionals that complement their project teams. Together we are sharing knowledge, learning, growing and continuing to be an integral part of supporting PM Group's ongoing expansion in the US.
We are seeking an experienced Staff Engineer, Process & Cleaning Validation to support manufacturing operations by ensuring processes and cleaning procedures are validated, compliant, and capable of consistently delivering high-quality products in a regulated sterile/aseptic environment.
Responsibilities - Lead process validation (PPQ) and cleaning validation activities.
- Develop validation strategies for new and existing products, processes, and equipment.
- Author, review, and execute validation protocols and reports.
- Analyze data and compile conclusions to support validation activities.
- Support change controls, deviation investigations, and CAPA initiatives.
- Collaborate with cross-functional teams including Manufacturing, Quality, and Technical Operations.
- Ensure compliance with cGMP requirements and regulatory expectations.
- Participate in internal and external audits and regulatory inspections.
- Drive continuous improvement initiatives related to validation programs.
Qualifications - Bachelor's degree in Engineering, Chemistry, Life Sciences, or a related technical discipline.
- 8+ years of experience in process validation and/or cleaning validation within a regulated manufacturing environment.
- Hands-on experience in sterile or aseptic manufacturing environments is required.
- Strong knowledge of cleaning validation principles, including residue limits, risk assessments, and risk-based validation approaches.
- Experience with lifecycle process validation and Process Performance Qualification (PPQ).
- Strong understanding of cGMP regulations and industry standards.
- Excellent analytical, problem-solving, and data interpretation skills.
- Proven technical writing and documentation experience.
- Ability to manage multiple priorities and projects simultaneously.
- Strong communication and cross-functional collaboration abilities.
- Demonstrated attention to detail and commitment to quality and compliance.
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