Commissioning & Qualification Lead Support

Job Description

Job Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• C&Q Lead Support for Capital and Local Project

Responsibilities:

• Support and lead contractors executing C&Q activities for capital and local projects.
• Assess projects and change controls from a commissioning and qualification (C&Q) perspective.
• Review and approve applicable C&Q documents, as needed, including PVP, CLIA, RV, IV, OV, PQ, TM, and EMPQ.
• Coordinate C&Q execution in alignment with the project schedule.
• Coordinate and align mechanical and automation validation activities for the assigned area, as required by the project.
• Support investigations and discrepancies identified during equipment commissioning and qualification.
• Support change control activities and document C&Q deliverables at each implementation step in Veeva or TrackWise through closure.
• Contribute to the development and revision of C&Q procedures.
• Attend operational and functional meetings related to assigned projects.

Qualifications:

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Biomedical, or related discipline) or equivalent technical/scientific background.
• Knowledge and experience in Commissioning & Qualification (C&Q) processes within the Life Science / Pharmaceutical industry.
• Strong understanding of GMP, GxP, FDA regulatory expectations, and industry practices related to equipment qualification and validation.
• Experience developing, reviewing, and approving qualification documentation including PVP, CLIA, Risk Assessments, IQ, OQ, PQ, TM, and EMPQ.
• Experience supporting capital projects, equipment installations, automation systems, and facility/process improvements in regulated manufacturing environments.
• Knowledge of validation lifecycle, change control processes, deviation/investigation management, and electronic quality systems (e.g., Veeva, TrackWise, Kneat).
• Ability to interpret engineering documentation including equipment specifications, URS, design documents, drawings, and technical reports.
• Strong project coordination skills with the ability to collaborate with Engineering, Operations, Quality, Automation, and external contractors.
• Experience supporting field execution activities, troubleshooting, and resolution of C&Q-related issues during project implementation.
• Strong technical writing, documentation review, and communication skills required to support qualification deliverables and project execution.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.