Sr. 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 Senior Validation Engineer with extensive experience supporting Fill-Finish operations capping systems lyophilization processes and utilities within GMP-regulated environments. This role is part of a high-performing CQV team responsible for developing executing and turning over validation and qualification deliverables for complex manufacturing systems. Senior Validation Engineers are expected to operate with a high degree of independence and resourcefulness proactively learning troubleshooting and driving activities forward with minimal supervision. The position requires strong engineering acumen including the ability to review and interpret drawings to support CQV and process-related activities. Flexibility is essential as responsibilities may shift quickly based on evolving project needs.

WORK LOCATION:

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

KEY RESPONSIBILITIES:

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

• Develop and execute CQV lifecycle documentation including FAT SAT IOQ and PQ for Fill-Finish equipment capping systems lyophilizers utilities and supporting process systems
• Generate execute and close validation lifecycle documents including RA VP IQ OQ PQ TM and VR
• Lead protocol development execution deviation resolution and final turnover packages
• Perform P&ID walkdowns and verify field installation against design documentation
• Support thermal mapping activities for temperature-controlled chambers warehouses and SIP processes
• Review and interpret engineering drawings specifications and vendor documentation to support CQV activities
• Provide technical input during equipment startup troubleshooting and issue resolution
• Support process and equipment readiness for tech transfer and manufacturing operations
• Assist in resolving regulatory observations or site issues related to validation or CQV
• Write review and revise qualification and validation documents including SOPs master plans URS FRS design specifications FAT documents and commissioning test procedures
• Prepare summary reports for validation verification commissioning and requalification activities
• Support change controls investigations and engineering documentation updates
• Execute periodic reviews and requalification activities for temperature-controlled systems
• Partner with Manufacturing Engineering Quality Facilities and Automation teams to ensure alignment and timely execution of CQV deliverables
• Coordinate with vendors and contractors to support equipment qualification and turnover
• Operate as a senior technical resource providing guidance to junior team members as needed

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 duties.

Education:

• Bachelors degree in Engineering Life Sciences or a related technical field.

Technical Experience:

• 711 years of experience in biotech pharmaceutical or regulated manufacturing environments
• Strong validation expertise in Fill-Finish capping lyophilization and utilities systems
• Experience supporting CQV activities including protocol development execution and turnover
• Knowledge of FDA cGMPs FMEA risk analysis and validation lifecycle principles
• Experience with automated production systems and computerized equipment validation
• Demonstrated ability to write IQ OQ PQ and CSV documentation and reports

Knowledge Skills and Abilities:

• Strong engineering mindset with the ability to interpret drawings and technical documentation
• Excellent verbal and written communication skills
• Ability to work independently with minimal supervision in fast-paced project environments
• Strong problem-solving skills and the ability to adapt quickly to changing priorities
• Ability to collaborate effectively with cross-functional teams and external partners

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.