Process & Validation Engineer (100% Travel) in Boston

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Job DescriptionJob Description

COMPANY DESCRIPTION :

Syner-G is a science-led, strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market, along with operational strategy and support. With a global team of 400 employees across North America and India, our goal is to help our partners navigate the complexities of product development and accelerate their journey to market.

We are a leading life sciences consultancy committed to advancing human health by helping organizations bring life-saving innovations to market faster, at scale, and with the highest quality.

Our team partners with a diverse range of clients across the life sciences industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital projects. We provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance, empowering our clients to navigate complexity and deliver impactful therapies to patients worldwide.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second 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

(Syner-G is seeking both Process and Validation Engineering Candidates)

PROCESS ENGINEER POSITION OVERVIEW :

Syner-G is seeking an experienced Process Engineer to assist with, but not limited to, process engineering, process development, materials & engineering sciences, technology transfer, facilities / utilities / technical services, and manufacturing processes. We are accepting applicants who will be able to travel remotely throughout to client sites in the United States.

WORK LOCATION :

Travel to client sites will 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.)

• Assist with the requirements specifications, design, functional requirements, development, commissioning, and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit.
• Lead start-up activities, including commissioning and qualification of facilities, utilities, and equipment (FUE).
• Assist with risk assessments, feasibility reviews, risk mitigations, and testing of process materials to ensure compliance with manufacturing requirements.
• Assist with the requirements specifications, design & development of process parameters, and the commissioning / validation of manufacturing processes for compliance with quality and regulatory requirements.
• Provide technical support for the product / process lifecycle and related activities.
• Support client requirements to lead or help process or engineering projects at vendors or other third-party contract companies, as needed.
• Provide support for improvement projects regarding processes and systems.
• Support or provide risk assessment and mitigation activities for process development, manufacturing, and testing as applicable.
• Provide technical support for scale-up activities from development to manufacturing, including but not limited to technology transfers and facilities improvements (e.g., utilities / equipment integration).
• Analyze and recommend improved technology to increase quality and efficiency.
• Provide technical analysis and support for new or improved process systems.
• Facilitate and schedule meetings with subject matter experts across the organization.
• Ensure compliance with cGMP, regulatory, and industry standards.

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 :

Technical Experience :

Knowledge, Skills, and 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.

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.

VALIDATION ENGINEER POSITION OVERVIEW :

We are 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.

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.)

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 :

Technical Experience :

Knowledge, Skills, and Abilities :

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 , , creed, , , or childbirth, personal appearance, family responsibilities, or preference, , political affiliation, source of income, place of residence, or origin, ancestry, , marital status, military veteran status, unfavorable discharge from military service, physical or mental , or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

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