Validation Engineer
About The Position
We are seeking a hands-on Validation Engineer with a strong background in mechanical or manufacturing engineering, who brings expertise in automated manufacturing environments, preferably within the life sciences or biopharma industry. This role combines engineering document reviews, equipment startup support, and process/manufacturing engineering with project management and cross-functional communication responsibilities. The ideal candidate will have experience in line layouts, fixture design, and 3D printing, with a preference for knowledge of filling and capping equipment. While this is not a controls engineering role, familiarity with PLCs and HMIs is required. The role also involves managing smaller projects and collaborating across teams to ensure successful execution in GMP-regulated environments. Proficiency in AutoCAD and SolidWorks is essential.
Requirements
- Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related life science field.
- 5–7 years of experience in biotech, pharmaceutical, or medical device industries.
- Strong understanding of GMP, FDA regulations, FMEA, and risk analysis.
- Experience with validation disciplines including Equipment, CSV, Method, and Process.
- Skilled in protocol generation and validation of automated production systems.
- Proficient in AutoCAD and SolidWorks.
- Familiarity with PLCs, HMIs, and automated manufacturing systems.
- Strong leadership and project management skills.
- Excellent communication and stakeholder engagement across functions.
- Ability to manage vendors and contractors effectively.
- Hands-on approach to engineering and problem-solving.
- Willingness to travel up to 100% for client site projects.
- Must have current work authorization.
- Unable to sponsor or take over sponsorship of an employment Visa at this time.
Nice To Haves
- Experience with high-speed fill-finish lines is a plus.
- Experience in automated manufacturing environments, preferably within the life sciences or biopharma industry.
- Experience in line layouts, fixture design, and 3D printing.
- Knowledge of filling and capping equipment.
Responsibilities
- Perform equipment qualifications including Commissioning, IQ, OQ, and PQ.
- Provide hands-on engineering support during equipment startup and validation activities.
- Conduct engineering document reviews and contribute to process improvement initiatives.
- Write, review, approve, and execute validation protocols and reports.
- Lead and mentor a small team of CQV engineers.
- Collaborate with scientists, technicians, engineers, and project managers to deliver validated equipment and facilities.
- Ensure validation programs meet GMP, FDA, and ISO standards.
- Support design and execution of verification tests and validation strategies.
- Coordinate with cross-functional teams and vendors to meet project milestones.
- Contribute to layout planning and fixture design, leveraging 3D printing where applicable.
- Communicate effectively across disciplines to define requirements and deliver solutions.
Benefits
- Market competitive base salary
- Annual incentive plan
- Robust benefit offerings
- Ongoing recognition and career development opportunities
- Generous flexible paid time off program
- Company paid holidays
- Flexible working hours
- Fully remote work options for most positions
- Ability to work “almost anywhere”
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
