Validation Engineer Lead

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 Validation Lead with 5-10 years of experience. The ideal candidate will have hands-on startup and commissioning experience with building and utility systems, as well as experience in generating and managing engineering lifecycle documentation.

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.)

• Lead and execute startup, commissioning and validation of building and utility systems, process equipment, and/or laboratory instrumentation.


• Generate and manage engineering lifecycle documentation, including impact assessments, URS/FRS, FAT/SAT documentation, ETOPs, P&IDs, and other technical documents.


• Conduct drawing walkdowns and verify field installation of equipment and utilities.


• Generate and execute protocols and reports.


• Collaborate with cross-functional teams to ensure successful project completion.


• Communicate effectively with stakeholders to provide updates and address issues.


• Ensure compliance with safety standards and regulations.

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 required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Education:

• Bachelor’s Degree in Engineering or a related field.

Technical Experience:

• 7-10 years of hands-on equipment startup and validation experience.


• Experience with generating and managing engineering lifecycle documentation.


• Experience with drawing walkdowns and verification of field installation.


• Experience with BMS, PCS, and CMMS systems.


• Experience with continuous manufacturing processes is desired


• Experience with PAT and process controls and instrumentation is desired

Knowledge, Skills, and Abilities:

• Strong understanding of validation lifecycle for equipment and utilities


• Excellent documentation and organizational skills.


• Ability to work independently and as part of a team.


• Strong communication and interpersonal skills.


• Detail-oriented with strong problem-solving abilities.

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.

COMPENSATION:

The expected salary range for this position is $90,000 to $150,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Applicants must have current work authorization when accepting a position at Sequoia. Currently, Sequoia 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.