Validation Consultant

Overview The Validation Consultant 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.

The Validation Consultant will support the Project Management Office (PMO) project portfolio at an aseptic manufacturing site. This is a long-term assignment anticipated to run from December 2026 through November 2028. 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.

Responsibilities

• The role is responsible for leading validation activities across facility systems, aseptic formulation and filling, device assembly, packaging, IT systems, warehouse operations, and Quality Control (QC) environments.
• Resources will be assigned multiple projects based on their technical expertise and will be expected to work independently with minimal oversight following onboarding and training.
• The successful candidate will lead commissioning, qualification, and validation efforts throughout the project lifecycle, including the development and execution of validation documentation, risk assessments, traceability matrices, IQ/OQ/PQ protocols, process validation activities, deviation investigations, change controls, and final reports.
• This is a highly collaborative, hands-on role requiring regular interaction with Engineering, Operations, Quality, Automation, and Project Management teams, as well as participation in project meetings and validation-focused initiatives.
• Candidates should be comfortable working on-site and supporting critical project activities, including occasional evening or weekend work during major project execution phases or site shutdowns.

Qualifications

• Pharmaceutical Validation & CQV Experience

• Experience generating and executing validation documentation in a GMP pharmaceutical environment.

• Ability to independently lead validation activities and deliverables.

• Authoring & Execution of Validation Documentation

• Validation Plans and Reports

• Risk Assessments

• Traceability Matrices

• Design Qualification/Design Review

• IQ/OQ/PQ and Process Validation Protocols & Reports

• Deviation, Change Control & GMP Compliance

• Investigation and documentation of deviations

• Change Control ownership and validation impact assessments

• Knowledge of GMP, FDA, EU Annex 15, and GAMP 5 requirements

• Manufacturing Equipment & Aseptic Processing

• Manufacturing equipment upgrades and production line modifications

• Aseptic formulation and filling equipment, including RABS systems

• Device assembly and packaging equipment validation

• Automation & Digital Manufacturing Systems

• SCADA, PLC, PAS-X, LMES, and related manufacturing systems

• Electronic validation systems such as HP ALM/TIMS and Veeva QualityDocs/Vault Quality

• Facility, Utility & Laboratory Systems

• HVAC, BMS, refrigeration, and facility utilities

• Laboratory and GMP facility modifications

• Process instrumentation, monitoring, and calibration systems

• Project Execution & Stakeholder Management

• Ability to manage multiple projects simultaneously

• Regular communication with project managers regarding status, risks, and escalations

• Participation in recurring project meetings and validation leadership activities

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.

RECRUITMENT AGENCIES NEED NOT APPLY