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. To learn more about who we are and what drives us watch our company video here.

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:

Syner-G is seeking a Validation Engineer to assist with the development and execution of validation protocols for various types of processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining implementing and maintaining the validation program.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented and changed as necessary.)

• Generate and execute life cycle documentation (FAT SAT IOQ PQ) for cleaning shipping facilities utilities systems equipment and processes for (re)qualification/(re)verification.
• Support validation activities for client projects including generation execution review and closure of validation life cycle documents
• Write review and revise Installation Operation and Performance qualification/verification related documents including any or all of the following: SOPs validation master plans guidelines and execution plans automation engineering design commissioning qualification or other technical documents user requirement specifications (URS) functional requirement specifications (FRS) detailed design specifications factory acceptance test documents (FAT) verification protocols and/or commissioning test procedures.
• Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.
• Write procedures investigations protocols reports change controls etc. to support the execution and closeout of validation work.
• Perform execution support activities including P&ID walkdowns drawing reviews and ETOP verification.
• Perform thermal mapping of temperature-controlled chambers warehouses and SIP processes.
• Support the resolution of regulatory observations or manufacturing site issues.
• Execute periodic reviews and requalification for temperature chambers.

QUALIFICATIONS AND REQUIREMENTS:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education experience skills knowledge and abilities accommodations may be made to enable individuals with disabilities to perform the essential duties.

Education:

• Bachelors degree in a related life science field.

Technical Experience:

• 3-10 years of experience within the biotech pharmaceutical or medical device industry.
• Knowledge and experience working with FDA cGMP FMEA and Risk Analysis required.
• Expertise in Process Equipment Utilities Clean Room and/or Computer Systems validation.
• Hands-on equipment start-up and troubleshooting experience is highly desired.
• Report writing experience for IQ OQ PQ.

Knowledge Skills and Abilities:

• Strong verbal and written communication skills and the ability to discuss technical topics with stakeholders and non-technical people is strongly desired.

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.