Mechanical Validation Engineer

Mechanical Validation Engineer

Fareva Richmond is a contract manufacturer of pharmaceutical and personal care consumer goods. The word Fareva means “Faire Rêver” (Make you dream) in Ardechois, the local dialect of the south east of France, the region where Fareva is based.

Fareva Associates are talented professionals who excel at providing our customers with cutting-edge expertise, technology and world class service.

At Fareva, Associates are held to a high standard and are guided by the principles of honestly, fairness, respect, confidentiality and trust. We value our Associates and recognize that our workforce is key to our success. As such, we are committed to providing our Associates with rewarding career opportunities. Fareva Richmond is currently looking for a Mechanical Validation Engineer.

Position Summary:

Proven ability to work independently to initiate, develop, plan and executed multiple verification projects. Perform functions to provide engineering support, management and compliance of large projects or initiatives. Execute equipment verification from the initial concept to final close-out. Display investigative or technological orientation with independence. Display initiative and commitment. Contribute to long-term strategic development of a complex project or site capital plan. Considered proficient in equipment verification field, creating credibility within team members and expanding capabilities of the group.

Manage the verification process: Able to create project plan, write and execute verification documents.

Position Responsibilities:

• Manage the site Engineering Verification Process. Position will function as a subject matter expert for project equipment validation. Develop verification (commissioning, IQ, OQ) documents for equipment compliance.
• Concurrently manage and execute projects verification from inception to project completion in support of site operations insuring safety, regulatory compliance, company standards, operational requirements and business needs. Provide project management guidance and business tools, utilizing a systematic approach to project execution. Prepare management reports and presentations.
• Attain a level of technical expertise within a specific field, and continues to expand his or her level of expertise in a particular field. Use expanded practical experience to handle complex tasks. Integrate intellectually complex and diverse pieces of information into practical business solutions.
• Exemplify cGMP compliance within the workplace by following and promoting site cGMP procedures. Incorporate cGMP and regulatory compliance into all assigned validation activities. Provide safety leadership within the workplace.
• Manage and oversee project verification contract work. Review and approve project contractor bids, request for information and change requests. Inspect or direct the inspection of work to ensure regulatory compliance.
• Provide advanced technical assistance to site operating groups through investigations, equipment qualification. Proactively look for and recommend improvements in site processes and procedures.

Education and Experience:

Engineering Degree (Mechanical or Chemical)

• Bachelor’s degree in related field
• 0-12 months experience in regulated cGMP manufacturing industry
• Experience in the development and execution of commissioning, IQ, OQ documents for new equipment installations.
• Working understanding of P&IDs, process flow diagram and equipment specifications
• Excellent coaching and influencing skills used to lead verification teams and resolve conflicts resulting in increased efficiency, cost savings, and compliance of our validation program.
• Ability to conduct Root Cause Failure Analysis and apply the principles to the verification document.
• Skilled at leading project teams and applying investigative/problem solving skills in fast paced environments.
• Experience in cGMP compliance and procedures

Technical Skill Requirements:

• Microsoft WORD, EXCEL, and Project scheduling software experience.
• Familiarity with codes including FDA cGMPs.

What we offer:

Competitive salaries, comprehensive health/vision/dental insurance, company paid short term disability, company paid life and accidental death insurance, 401(k) plan match of 4.5% with immediate vesting, generous employee referral program, paid vacation annually, paid holidays annually. Manufacturing employees also receive company paid work shoes, uniforms and prescription safety eyeglasses.