Quality Associate, Commissioning & Validation

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 ways. In 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 BioSpace's 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. 

For more information, visit www.Synergbiopharma.com

POSITION OVERVIEW:
We are seeking a Quality Associate, Commissioning & Validation (Mid to Junior level) to support the commissioning and validation of a manufacturing facility. This role is responsible for reviewing, verifying, and documenting that equipment and systems are commissioned, qualified, and validated in alignment with GMP expectations. You will work closely with engineering and technical teams to ensure activities remain compliant, complete, and on schedule. This is a hands-on quality role requiring strong attention to detail and the confidence to identify gaps and advocate for corrective actions when needed.

WORK LOCATION:
On-site presence at manufacturing or project locations is required during active commissioning activities.

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

Commissioning and Qualification

• Review commissioning, IQ, OQ, and PQ protocols and reports for GMP equipment and systems
• Verify execution aligns with approved protocols and regulatory expectations
• Ensure deviations, discrepancies, and punch list items are documented and resolved
• Confirm traceability from requirements through execution and final approval

Quality Oversight

• Provide quality review and approval of validation deliverables
• Ensure documentation meets data integrity and GMP standards
• Support risk assessments, impact assessments, and change controls tied to commissioning activities
• Escalate compliance risks clearly and early

Cross-Functional Collaboration

• Work directly with engineering, automation, facilities, and manufacturing teams
• Support technical teams by clarifying quality expectations and documentation needs
• Help teams close gaps without unnecessary delays

Schedule and Readiness Support

• Track review timelines and follow up to maintain progress
• Support inspection readiness related to commissioning and validation activities
• Assist with responses to internal or external audit questions

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 essential functions.

Education:

• Bachelor’s degree in science, engineering, or a related field

Technical Experience:

• 2 to 5 years of experience in GMP manufacturing, quality, validation, or commissioning support
• Working knowledge of equipment qualification and validation lifecycle
• Familiarity with GMP documentation standards and regulatory expectations

Preferred Experience:

• Experience supporting facility start-ups, expansions, or tech transfers
• Exposure to commissioning and qualification of manufacturing equipment or utilities
• Understanding of FDA, EMA, and ICH GMP expectations
• Experience working in fast-paced, cross-functional project teams

Skills and Attributes:

• Detail-oriented with strong documentation discipline
• Comfortable working with technical and engineering teams
• Able to manage multiple reviews simultaneously
• Clear communicator capable of raising issues constructively
• Practical mindset focused on compliance and execution

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.

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 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 is an E-Verify employer.