Sr. Process Engineer

Job Description

Job Description

COMPANY DESCRIPTION :

Syner-G BioPharma Group 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 BioPharma Group 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

POSITION OVERVIEW :

We are seeking a Sr. Process Engineer with a strong background in mechanical or manufacturing engineering and hands-on experience in automated manufacturing environments, preferably within the life sciences or biopharma industry. This role will focus on the integration of a central temperature control unit (TCU) with portable jacketed mixing vessels, rather than the design of the mixers themselves. The ideal candidate will have experience managing technical projects involving utility systems, cleanroom installations, and vendor coordination. Familiarity with PLCs, HMIs, and building automation systems (BAS) is required.

WORK LOCATION :

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

KEY RESPONSIBILITIES :

• Manage the integration of a temperature control system with 200-liter and 500-liter Millipore portable jacketed mixers across multiple cleanroom locations
• Oversee installation of quick-connect supply and return lines for glycol-based fluid in designated formulation and filling rooms
• Coordinate installation of remote temperature control interfaces and ensure BAS integration for monitoring, trending, and alarming
• Lead cross-functional collaboration with internal teams, vendors, and contractors to ensure timely and compliant execution
• Ensure all cleanroom piping is installed using 316 stainless steel and meets regulatory standards
• Manage procurement, commissioning, startup, and qualification of the TCU and associated components
• Provide technical oversight and documentation throughout the project lifecycle
• Support calibration and validation activities in alignment with cGMP and FDA requirements

QUALIFICATIONS & REQUIREMENTS :

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. 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 BioPharma Group 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 BioPharma is an E-Verify employer.