Validation Consultant

PM Group•Zebulon, NC

1d•Onsite

About The Position

PM Group is hiring a Validation Consultant to join its growing Outsourced Technical Services (OTS) team near Zebulon, North Carolina. The role supports the Project Management Office project portfolio at an aseptic manufacturing site. It is a long-term assignment anticipated to run from December 2026 through November 2028. The consultant will lead validation activities across facility systems, aseptic formulation and filling, device assembly, packaging, IT systems, warehouse operations, and Quality Control environments. Work is assigned across multiple projects according to technical expertise. After onboarding and training, the consultant is expected to work independently with minimal oversight. This is a collaborative, hands-on, on-site role involving regular work with Engineering, Operations, Quality, Automation, and Project Management teams, along with participation in project meetings and validation-focused initiatives. Occasional evening or weekend work may be needed during major project execution phases or site shutdowns. PM Group is an employee-owned international project delivery firm with more than 4,000 people and over 50 years of industry experience. It serves the pharmaceutical, food, biotech, medical technology, and mission-critical sectors.

Requirements

Experience generating and executing validation documentation in a GMP pharmaceutical environment.
Ability to independently lead validation activities and deliverables.
Experience with validation plans and reports, risk assessments, traceability matrices, design qualification or design review, and IQ/OQ/PQ and process validation protocols and reports.
Experience investigating and documenting deviations and owning change controls and validation impact assessments.
Knowledge of GMP, FDA, EU Annex 15, and GAMP 5 requirements.
Experience with manufacturing equipment upgrades and production line modifications.
Experience with aseptic formulation and filling equipment, including RABS systems.
Experience validating device assembly and packaging equipment.
Experience with automation and digital manufacturing systems such as SCADA, PLC, PAS-X, and LMES.
Experience with electronic validation systems such as HP ALM/TIMS and Veeva QualityDocs/Vault Quality.
Experience with HVAC, BMS, refrigeration, and facility utilities.
Experience with laboratory and GMP facility modifications, process instrumentation, monitoring, and calibration systems.
Ability to manage multiple projects simultaneously.
Ability to work on-site and collaborate with project stakeholders.

Responsibilities

Lead commissioning, qualification, and validation activities throughout the project lifecycle.
Develop and execute validation documentation, including validation plans and reports, risk assessments, traceability matrices, design qualification or design review materials, and IQ/OQ/PQ protocols and reports.
Lead process validation activities.
Investigate and document deviations, own change controls, and conduct validation impact assessments.
Support validation across facility systems, aseptic formulation and filling, device assembly, packaging, IT systems, warehouse operations, and QC environments.
Work independently across multiple assigned projects following onboarding and training.
Communicate project status, risks, and escalations to project managers.
Participate in recurring project meetings and validation leadership activities.
Collaborate regularly with Engineering, Operations, Quality, Automation, and Project Management teams.
Support critical project activities, including occasional evening or weekend work during major project execution phases or site shutdowns.