Staff Engineer – Process & Cleaning Validation

About the Role

PM Group's Outsourced Technical Services (OTS) team near Zebulon, NC, is 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.