Validation Engineer

POSITION OVERVIEW:

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.

WORK LOCATION:

Travel to client sites may be required up to 100%, depending on project demands and client expectations.

KEY RESPONISIBILITIES:

• 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.

QUALIFICATIONS & REQUIREMENTS:

Education:

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related life science field.

Technical Experience:

• 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.
• Experience with high-speed fill-finish lines is a plus.

Skills and Abilities:

• 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.

ESSENTIAL FUNCTIONS:

Physical Demands:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars.  This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.