Sr. Process Engineer na Syner-G BioPharma Group

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:

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related technical field

Technical Experience:

• 4 to 7 years of experience in technical project management within automated manufacturing environments
• Experience in life sciences or biopharma preferred
• Familiarity with temperature control systems, jacketed vessels, and cleanroom utility integration
• Proficient in AutoCAD and SolidWorks
• Working knowledge of PLCs, HMIs, and BAS systems
• Experience with cGMP manufacturing and FDA-regulated environments
• Proficient in MS Office, MS Project, and Visio

Knowledge, Skills and Abilities:

• Strong organizational and project management skills
• Excellent cross-functional communication and stakeholder engagement
• Ability to manage vendors and contractors effectively
• Hands-on approach to problem-solving and implementation
• Willingness to travel to client sites as needed

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.