Lead Validation Specialist

Lead Validation Specialist – Salas O’Brien / Process Plus is a full‑service engineering firm providing Commissioning and Qualification / Validation (C&Q) services to the food, pharmaceutical and biotech industries. Validation specialists develop and execute C&Q protocols (e.g., IQ/OQ/PQ) for facilities, equipment, control systems, utilities and HVAC environments, meeting FDA cGMP requirements and Good Engineering Practices (GEP).

• Conduct cGMP audits, gap analyses, and impact assessments to scope validation efforts.
• Develop system specifications per GAMP and/or GEP.
• Develop project Commissioning and Validation Master Plans (CVMP) describing scope, intent, and strategy.
• Interface with OEMs, construction managers, and contractors to develop and execute commissioning protocols and checklists.
• Interface with end users to develop and execute validation protocols (IQ/OQ/PQ); compile and analyze qualification/validation data.
• Develop Trace Matrices (TM) illustrating the relation of system requirements (UR/FS/DS) to field verifications (IQ/OQ/PQ).
• Develop Summary Reports (SR) that clearly and concisely summarize C&Q efforts.
• Represent and defend validation results to client auditors and regulatory authorities.
• Lead validation specialists in the execution of project tasks.
• Perform other related duties as required and/or assigned.

• Organized, analytical, and self‑motivated with considerable knowledge of FDA regulations and the food, pharmaceutical, and biotech industries.
• Manage projects on an administrative and technical level, including communication with customers (status updates for schedule, progress, and cost).
• Facilitate the career development of VS‑I and VS‑II specialists.
• Manage multiple projects of various sizes simultaneously.
• Directly responsible to the Best Practice Lead (VS‑III) / Department Manager (DM) and the Project Manager (PM) for project execution.
• Work independently and as a team leader.
• Evaluate engineering documents (specifications, wiring diagrams, P&IDs, HVAC/mechanical drawings, architectural layouts).
• Configure and operate portable measuring instrumentation for verification data.
• Exhibit excellent written, verbal, and presentation skills.
• Assess project scope, manage change, and solve problems.
• Display professional deportment when interfacing with customers, vendors, and trade contractors.

• Bachelor’s degree in a scientific, technical, or engineering discipline with 5–7 years of experience in an FDA‑regulated environment.
• Associate degree in the same disciplines or skilled technician/military veteran with 7–10 years of experience in an FDA or other regulated environment.
• Proficiency in Windows and Microsoft Office (Word and Excel).
• Proficiency in the use of field measuring instrumentation.
• Considerable knowledge of FDA regulations/cGMPs and Good Automated Manufacturing Practices (GAMP).

• Hours average 40 per week; may require additional hours including evenings and weekends.
• Work performed in an indoor office setting, a client manufacturing facility, and/or a client construction site.
• Wearing PPE/gowning may occasionally be required.
• Travel: moderate – 40% including immediate tri‑state and regional travel.

• Ability to work at a computer terminal for extended periods.
• Ability to stand and walk for extended periods.
• Light lifting up to 20 lbs.
• Ability to speak to and hear employees/clients via phone or in person.
• Body motor skills sufficient to move around an office, manufacturing, and construction environment.
• Ability to analyze unique situations and develop appropriate response.

• Mid‑Senior level

• Full‑time

• Project Management, Design, and Engineering
• Design Services