RemoteOn-site work is implied by go-live floor support at the manufacturing site; remote work options are general company language, not specific to this position.
No H1B Sponsorship
About the job
Requirements
A bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical field.
Strong pharmaceutical manufacturing or Operations background combined with hands-on Manufacturing Execution System (MES) experience.
Ability to translate shop-floor manufacturing processes into functional MES requirements and workflows.
Experience developing Functional Requirements Specifications (FRS) or user requirements and supporting MES solution design.
Hands-on experience with User Acceptance Testing (UAT), electronic batch record (eBR) testing, operational readiness, and go-live support.
Working knowledge of Good Manufacturing Practices (GMP), 21 CFR Part 11, data integrity, and validation requirements.
Ability to work effectively between Operations and technical MES teams.
Ability to mentor junior engineers and contribute to team development and knowledge sharing.
Responsibilities
Own and develop Functional Requirements Specifications (FRS), translating manufacturing processes and business needs into clear MES functional requirements.
Work with Manufacturing subject matter experts and MES technical/configuration teams to ensure the solution reflects intended manufacturing processes and operator workflows.
Plan, coordinate, and execute User Acceptance Testing (UAT), including developing test scenarios and coordinating with Operations subject matter experts.
Review and challenge electronic batch records, recipes, workflows, calculations, prompts, exception handling, and user interactions from an operational perspective.
Support operational readiness, including dry runs, mock batch execution, and go-live preparation.
Develop and deliver MES/eBR user training and support operator readiness.
Provide hands-on floor support during go-live, hypercare, and stabilization.
Troubleshoot MES/eBR workflow and usability issues across Manufacturing, Quality, Automation, IT/OT, and MES teams.
Support validation and qualification activities as required, ensuring alignment with GMP and site procedures.
Desired Qualifications
Previous experience as a manufacturing operator, technician, manufacturing associate, or Operations subject matter expert is highly desirable.
Experience with PAS-X, PharmaSuite, Syncade, Opcenter, or similar MES/eBR platforms is preferred.
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 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.
We are seeking a Sr. Automation Engineer with 5-15 years of experience to serve as a subject matter expert for automation MES, providing QA/Validation oversight for Manufacturing Execution System (MES) and Electronic Batch Record (eBR) implementations, qualification activities, and system lifecycle management. This individual will partner closely with Manufacturing, Quality, Validation, Automation, and IT/OT teams to ensure successful system deployment, qualification, and ongoing compliance.
KEY RESPONSIBILITIES:
(This list is not exhaustive and may be supplemented or adjusted as needed.)
Own and develop Functional Requirements Specifications (FRS), translating manufacturing processes and business needs into clear MES functional requirements.
Work closely with Manufacturing SMEs and MES technical/configuration teams to ensure the solution accurately reflects intended manufacturing processes and operator workflows.
Plan, coordinate and execute User Acceptance Testing (UAT), including development of test scenarios and coordination with Operations SMEs.
Review and challenge electronic batch records, recipes, workflows, calculations, prompts, exception handling and user interactions from an operational perspective.
Support operational readiness, including dry runs, mock batch execution and go-live preparation.
Develop and deliver MES/eBR user training and support operator readiness.
Provide hands-on floor support during go-live, hypercare and stabilization.
Troubleshoot MES/eBR workflow and usability issues across Manufacturing, Quality, Automation, IT/OT and MES teams.
Support validation and qualification activities as required, ensuring alignment with GMP and site procedures.
QUALIFICATIONS AND REQUIREMENTS:
Education
Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical field.
Technical Skills:
Strong pharmaceutical manufacturing/Operations background combined with hands-on MES experience.
Demonstrated ability to translate shop-floor manufacturing processes into functional MES requirements and workflows.
Experience developing FRS/user requirements and supporting MES solution design.
Hands-on experience with UAT, eBR testing, operational readiness and go-live support.
Knowledge, Skills and Abilities:
Previous experience as a manufacturing operator, technician, manufacturing associate or Operations SME is highly desirable.
Experience with PAS-X, PharmaSuite, Syncade, Opcenter or similar MES/eBR platforms preferred.
Working knowledge of GMP, 21 CFR Part 11, data integrity and validation requirements.
Strong communication skills with the ability to work effectively between Operations and technical MES teams.
Ability to mentor junior engineers and contribute to team development and knowledge sharing.
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 employer. 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.