Lead Validation Specialist

Salas O’Brien, Inc.; Cincinnati (OH); On-site; USD 75,000 - 95,000; Full time

Job summary

A full-service engineering firm seeks a Lead Validation Specialist in Cincinnati, OH. The role involves conducting audits, developing validation protocols, and leading project teams to ensure compliance with FDA regulations. Candidates should have a Bachelor's degree and 5-7 years of relevant experience along with strong analytical and communication skills. This position requires moderate travel and work in various settings including office and manufacturing environments.

Qualifications

• 5 to 7 years of experience in an FDA regulated environment.
• Proficiency in configuring and operating portable measuring instrumentation.
• Excellent written, verbal, and presentation skills.

Responsibilities

• Conduct cGMP Audits, Gap Analysis, and Impact Assessments.
• Develop project Commissioning and Validation Master Plans.
• Lead validation specialists in executing project tasks.

Skills

Organization

Analytical skills

Technical evaluation

Communication

Problem-solving

Education

Bachelor’s degree in a scientific, technical, or engineering discipline

Associate degree or skilled technician/military veteran with relevant experience

Tools

Microsoft Office (Word and Excel)

Field measuring instrumentation

Job description

Cincinnati, OH - Merchant, 135 Merchant St, Suite 300, Cincinnati, OH 45246, USA

Salas O’Brien / Process Plus is a full-service engineering firm that provides 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 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).

ESSENTIAL JOB FUNCTIONS

• Conduct cGMP Audits, Gap Analysis, and Impact Assessments as required to scope validation efforts.
• Develop system specifications per GAMP and/or Good Engineering Practices (GEP).
• Develop project Commissioning and Validation Master Plans (CVMP) that describe C&Q 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 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.

JOB REQUIREMENTS

A Lead Validation Specialist (VS-III or VS-IV) is organized, analytical, and self-motivated, possessing considerable knowledge of the food, pharmaceutical, and biotech industries and FDA regulations.

• A VS-III or VS-IV 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 VS-III or VS-IV is responsible for facilitating the career development of a VS-I or VS-II.
• A VS-III or VS-IV is expected to manage multiple projects of various sizes, simultaneously.
• A VS-III or VS-IV is directly responsible to the Best Practice Lead (VS-III) / Department Manager (DM) administratively and the Project Manager (PM) for the successful execution of the project.

ADDITIONAL REQUIREMENTS

• 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).

WORKING CONDITIONS

• Hours average 40 per week; may require additional hours including evening and weekends depending on business needs.
• 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 the immediate tri-state and regional travel.

Physical Demands

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

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.