Analysis Skills, Asepsis, Biology, Biotech and Pharmaceutical, Business Growth, Business Strategy, Change Control, Chemistry, Communication Skills, Continuous Improvement, Corporate Social Responsibility, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Customer Support/Service, Data Analysis, Data Collection, Detail Oriented, Disability Accommodations, External Audit, Green Business, Industry Standards, Internal Audit, Maintain Compliance, Manufacturing, Manufacturing Operations, Multitasking, Operational Support, Operations Processes, Outsourcing, Problem Solving Skills, Process Improvement, Process Validation, Project Lifecycle, Regulations, Regulatory Compliance, Regulatory Requirements, Risk, Risk Analysis, Strategic Planning, Sustainability, Team Player, Technical Operations, Technical Writing, Validation Plan, Writing Skills
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.
PM Group is an employee owned, international project delivery firm with a team of 4,000+ people. We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organizations. We are focused on growing a sustainable business centered on our people, our clients and trade partners.
:
- 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.
:
- 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.
All of your information is confidential according to EEO guidelines.
Why PM Group?
As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2026 business strategy. Click here to read more in our 2025 Environmental, Social and Governance Report.
Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.
PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.
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