CQV Engineer

Trinity's Engineering & EHS Workforce Solutions business line is seeking a Commissioning, Qualification, and Validation (CQV) Engineer on behalf of our Life Sciences/Built Pillar. This position is project based with an estimated duration of one year. Project duration is not guaranteed. Extension is possible, though not guranteed. The role W-2 and fully benefits eligible including Paid Time Off (PTO), holiday pay, Medical, Dental, Vision benefits, and 401K plus company match.

We are seeking a detail-oriented and motivated individual to join our team. The Commissioning, Qualification, and Validation (CQV) Engineer is responsible for ensuring that equipment, utilities, facilities, and computerized systems used in regulated manufacturing environments are properly designed, installed, tested, and qualified to meet regulatory and operational requirements. The CQV Engineer supports the full lifecycle of systems—from commissioning and IQ/OQ/PQ execution through validation documentation and turnover—to ensure readiness for GMP production.

DUTIES AND RESPONSIBILITIES:

• Draft and implement Quality System documentation designed to establish good validation practices within the organization.
• Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.
• Design validation approaches, supported by appropriate statistical analyses, perform and/or coordinate all validation activities, analyze and assemble results, and draft validation reports.
• Provide input on user and/or functional requirements of current and future processing equipment, and draft appropriate documentation. Additionally, interface with Contract Manufacturers to ensure all relevant user and functional requirements are met.
• Provide support to non-engineering staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
• Execute assigned duties on time and pro-actively communicate delays and other issues to validation manager and other relevant stakeholders.
• Comply with all regulatory, corporate, and Quality System policies.

REQUIRED SKILLS/ABILITIES:

• Experience in the areas of Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.)
• Experience with Process Engineering or Process Validation
• Working knowledge of Computer Systems Validation lifecycle and documentation.
• Proficient in Microsoft Word, Excel, PowerPoint.
• Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.
• Must demonstrate strong communication, interpersonal and teamwork skills.
• A strong understanding of technical writing and presentation skills is required.
• Experience with typical validation tools (e.g., data loggers) and validation software a plus
• Familiarity with ASTM E2500 a plus

EDUCATION AND EXPERIENCE:

• B.S. / M.S. in engineering or another relevant discipline.
• Minimum of 8+ years of experience working within a medical device environment or other FDA regulated environments. Experience with device-biologic combination products is highly desirable.
• Equivalent combinations of education and experience will also be considered.

PHYSICAL REQUIREMENTS:

The physical requirements listed here represent those an employee must meet to perform the essential functions of this role successfully. Reasonable accommodations can be made to enable individuals with disabilities to perform these functions.

• Regularly required to sit, use hands, and communicate verbally.
• Occasionally required to stand, walk, and reach with hands and arms.
• Must occassionally lift and/or move up to 10 pounds.