Commissioning / Qualification / Validation SpecialistJob Summary: Salas O'Brien is a full-service engineering firm that provides Commissioning and Qualification / Validation (CQV) services to the life sciences (pharmaceutical / biotech industries), food, and cosmetics industries . CQV Specialists develop and execute CQV protocols (e.g., IQ/OQ/PQ) for these industries. Protocols may include verification of manufacturing / packaging facilities, process and packaging equipment, control systems, utilities, and HVAC / environmental conditions. Commissioning is executed to document delivery of a safe, functional system per Good Engineering Practices (GEP) and qualification is executed to verify conformance to the FDA's current Good Manufacturing Practices (cGMPs).
Responsibilities:The responsibilities listed are fundamental to the position and must be performed successfully to achieve the key performance objectives of the role. Other responsibilities may be assigned.
- Conduct cGMP Audits, Gap Analysis, and Risk / Impact Assessments as required to scope CQV efforts.
- Develop system specifications per GAMP and / or Good Engineering Practices (GEP).
- Develop project CQV Master Plans (CQVP) that describe CQV scope, intent, and strategy.
- Interface with Original Equipment Manufacturers (OEM), Construction Managers (CM), and construction contractors to develop and execute commissioning protocols and checklists.
- Interface with the end user to develop and execute validation protocols (IQ/OQ/PQ). Execution includes compiling and analyzing qualification / validation data.
- Develop Trace Matrices (TM) to illustrate the relation of system requirements (UR/FS/DS - User Requirements / Functional Specifications / Design Specifications) and field verifications (IQ/OQ/PQ).
- Develop Summary Reports (SR) that clearly and concisely summarize CQV 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.
Job Requirements: - A CQV Specialist (CQVS-3 or CQVS-4) is organized, analytical, and self-motivated, possessing considerable knowledge of the food, pharmaceutical, and biotech industries and FDA regulations.
- A CQVS-3 or CQVS-4 is expected to manage projects on an administrative and technical level, including communication with the customer (e.g., status updates for schedule, progress and cost).
- A CQVS-3 or CQVS-4 is responsible for facilitating the career development of a VS-1 or VS-2.
- A CQVS-3 or CQVS-4 is expected to manage multiple projects of various sizes, simultaneously.
- A CQVS-3 or CQVS-4 is responsible to the Best Practice Lead (CQVS-5) / Department Manager (DM) administratively and the Project Manager (PM) for the successful execution of the project.
Additionally, a CQVS-3 or CQVS-4:
- Must be able to work both independently and as a team leader.
- Must possess the technical aptitude to evaluate engineering documents including specifications, wiring diagrams, P&ID's, HVAC / mechanical system drawings, and architectural layouts.
- Must possess the technical aptitude and experience necessary to configure and operate portable measuring instrumentation used to gather verification data.
- Must possess excellent written, verbal and presentation skills.
- Must demonstrate the ability to assess project scope, manage change, and solve problems.
- Must display professional deportment when interfacing with customers, vendors, and trade contractors.
Education/Experience: - Bachelor's degree in a scientific, technical, or engineering discipline with 5 to 7 years of experience working within an FDA regulated environment.
- Associate degree in the same disciplines or skilled technician / military veteran with 7 to 10 years of experience working within an FDA or other regulated environment.
- Proficiency in Windows & Microsoft Office applications (Word and Excel).
- Proficiency in the use of field measuring instrumentation.
- Considerable knowledge of FDA regulations / cGMPs, and Good Automated Manufacturing Practices (GAMP).
Location: Columbus, OH
Travel: Up to 25%
Compensation: $90,000-$100,000
Benefits: This role is eligible for performance-based bonuses and a comprehensive U.S. based benefits package, including:
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off and company holidays
- Wellness programs and employee assistance resources
- Professional development support
For more information, visit our full benefits overview here.
