Validation Engineer

COMPANY DESCRIPTION:

A career here is life-enhancing.

At Syner-G we enable our people to build careers that impact positively on their quality of life. Through our expertise insight consulting and management skills we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful varied and thought-provoking work with a strategic emphasis a solutions-driven approach and significant real-world outcomes from science to delivery/success.

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow we support them in their learning and we reward them in so many different return they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpaces prestigious Best Places to Work 2026 award for the third 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.

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POSITION OVERVIEW
We are seeking a Validation Engineer with 47 years of experience to support the development execution and management of validation activities across equipment utilities facilities computerized systems and manufacturing processes. This role is responsible for ensuring compliance with internal quality standards and regulatory requirements by generating executing and maintaining validation lifecycle documentation. The Validation Engineer will play a key role in supporting operational readiness tech transfer and continuous improvement initiatives.

KEY RESPONSIBILITIES
(This list is not exhaustive and may be supplemented or adjusted as needed.)

• Generate and execute validation lifecycle documentation (FAT SAT IOQ PQ) for equipment utilities facilities cleaning processes shipping systems and other GMPregulated assets.
• Support validation activities for internal and client tech transfer projects including authoring executing reviewing and closing validation documents such as risk assessments validation plans IQ OQ PQ test methods and validation reports.
• Write review and revise qualification and verification documents including SOPs master validation plans execution plans URS FRS design specifications FAT documentation verification protocols and commissioning test procedures.
• Prepare summary reports for validation verification commissioning and requalification activities.
• Develop and support procedures investigations protocols reports and change controls for Maintenance Engineering and Quality functions.
• Perform P&ID walkdowns to verify installation and system readiness.
• Conduct thermal mapping of temperaturecontrolled chambers warehouses and SIP processes.
• Support resolution of regulatory observations audit findings and manufacturing site issues related to validation.
• Perform periodic reviews and requalification activities for temperaturecontrolled systems and other validated assets.

QUALIFICATIONS AND REQUIREMENTS
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education

• Bachelors degree in a life science engineering or related technical field.

Technical Experience

• 47 years of experience in the biotech pharmaceutical or medical device industry.
• Strong knowledge of FDA cGMP requirements FMEA and riskbased validation principles.
• Handson validation experience in equipment computerized systems (CSV) analytical methods and process validation.
• Experience generating protocols for automated production systems with emphasis on computerized equipment and systems validation.
• Demonstrated experience writing IQ OQ PQ and CSV reports.
• Experience with executing validation scope for CTUs Lab Equipment misc. equipment.

Knowledge Skills and Abilities

• Strong verbal and written communication skills with the ability to explain technical concepts to nontechnical stakeholders.
• Detailoriented with strong organizational and documentation skills.
• Ability to work independently and collaboratively in a fastpaced regulated environment.
• Strong problemsolving skills and the ability to support investigations and rootcause analysis.

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.

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

LEGAL STATEMENT:

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions including the recruiting hiring placement training availability promotion compensation evaluation disciplinary actions and termination of employment (if necessary) are made without regard to the employees 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 is an E-Verify employer.