Validation Engineer

Validation Engineer

Syner-G BioPharma Group is a science-led, strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market, along with operational strategy and support. With a global team of 400 employees across North America and India, our goal is to help our partners navigate the complexities of product development and accelerate their journey to market.

We are a leading life sciences consultancy committed to advancing human health by helping organizations bring life-saving innovations to market faster, at scale, and with the highest quality.

Our team partners with a diverse range of clients across the life sciences industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital projects. We provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance, empowering our clients to navigate complexity and deliver impactful therapies to patients worldwide.

Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership, and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

Syner-G is seeking a hands-on Validation Engineer with 8–10 years of experience in validation execution to support the development and implementation of validation protocols across various pharmaceutical and biotech processes. This role is best suited for a professional who thrives in a fast-paced, execution-focused environment and prefers actively contributing to validation work over managing projects from a distance.

The ideal candidate will have deep expertise in sterilization cycle validation, including the handling and interpretation of Biological Indicators (BIs). Experience with isolators and Vaporized Hydrogen Peroxide (VHP) systems is highly desirable. This position requires weekly travel to Lee, MA (Monday–Friday) with return home on weekends.

In addition to executing validation activities, the engineer may lead a small team of CQV (Commissioning, Qualification, and Validation) professionals to ensure quality, compliance, and performance across client projects.

Key responsibilities include:

• Execute validation activities including Commissioning, IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification)
• Perform sterilization cycle validations, including handling and analysis of Biological Indicators (BIs)
• Support validation of isolators and VHP systems
• Write, review, and execute validation protocols and reports
• Travel to Lee, MA Monday through Friday; return home on weekends
• Ensure validation programs meet GMP, FDA, and ISO regulatory requirements
• Collaborate with scientists, engineers, and project managers to deliver validated equipment and facilities
• Lead and mentor a small team of CQV engineers as needed
• Develop and communicate expectations for quality performance and continuous improvement
• Interact with cross-functional teams to meet project milestones and deliverables
• Assist in risk assessments, FMEA, and other quality system activities

Qualifications and requirements include:

• Bachelor’s degree in a related life science or engineering field
• 8–10 years of hands-on validation experience in the biotech, pharmaceutical, or medical device industry
• Strong background in equipment, process, and sterilization validation
• Experience with FDA regulations, cGMP, FMEA, Risk Analysis, and spreadsheet validation
• Protocol generation and execution experience, especially with automated and computerized systems
• Strong leadership and mentoring capabilities
• Excellent written and verbal communication skills
• Ability to work independently and collaboratively in a team environment
• Willingness to travel up to 100% for client site work

Essential functions include:

• Regular use of computer, keyboard, and mouse
• Frequent walking, sitting, and occasional lifting of up to 25 pounds
• Occasional standing, stooping, or kneeling
• Visual acuity for close work and screen use

Work Environment:

• Indoor, temperature-controlled environment with moderate noise levels and bright lighting typical of office and lab settings

Total rewards program 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.

At this time, Syner-G is unable to sponsor or take over sponsorship of an employment Visa.

Syner-G BioPharma Group is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.