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Syner-G BioPharma Group
Engineering & Architecture 1h ago

Principal Process Engineer

Syner-G BioPharma Group
United StatesUnited States
Full-time
Not Disclosed
Senior-Level

Job Description

Key Skills Required

Master these to land this role

Process EngineeringMechanical Engineering3D ModelingAutomation EngineerCAD Designer

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Syner-G is seeking a Principal Process Engineer with 18+ years of experience to provide strategic technical leadership in the design, optimization, and automation of complex manufacturing and laboratory processes. This role serves as a senior technical authority responsible for shaping long-term process strategy, leading major engineering and automation initiatives, and driving innovation across multiple client programs. The Principal Process Engineer will guide cross-functional teams, mentor engineering staff, and ensure the development of highly robust, scalable, and efficient processes that support development, clinical, and commercial operations.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or changed as necessary.)

  • Lead enterprise-level process development, optimization, and scale-up initiatives across upstream, downstream, or formulation operations.
  • Serve as a senior technical authority for process automation strategy, including advanced control methodologies, digital transformation, and integration of next-generation technologies.
  • Develop, review, and approve complex engineering documentation such as PFDs, P&IDs, engineering studies, equipment specifications, and process descriptions.
  • Conduct high-level process modeling, statistical analysis, and system-wide assessments to drive strategic improvements and long-term process reliability.
  • Lead commissioning, qualification, and startup of major process systems, automated equipment, and integrated manufacturing platforms.
  • Partner with automation, engineering, operations, and digital teams to implement advanced monitoring tools, predictive analytics, and data-driven process control solutions.
  • Troubleshoot critical process deviations, equipment failures, and automation issues, providing expert-level guidance to engineering teams and client stakeholders.
  • Lead multi-site technology transfer activities, ensuring process scalability, consistency, and alignment across development, clinical, and commercial environments.
  • Oversee vendor relationships and manage complex equipment upgrades, process redesigns, and automation projects with significant technical and business impact.
  • Drive continuous improvement initiatives focused on yield, throughput, cost efficiency, and long-term process robustness.
  • Mentor, coach, and develop engineering staff at all levels, contributing to organizational technical capability and succession planning.
  • Advise internal leadership and client executives on process strategy, risk mitigation, and long-term technical planning.
  • Influence organizational engineering standards, best practices, and technology roadmaps.

QUALIFICATIONS AND REQUIREMENTS:

Education

  • BS/MS in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or a related technical field preferred.

Experience

  • 18+ years of experience in process engineering within biotech, pharmaceutical, or advanced manufacturing environments.
  • Extensive experience with automated process equipment such as bioreactors, chromatography systems, filtration skids, or formulation systems.
  • Deep expertise with process automation platforms (e.g., DeltaV, Rockwell, Siemens, SCADA/PLC systems).
  • Demonstrated leadership in process development, scale-up, equipment integration, and process optimization across multiple programs or sites.
  • Proven ability to lead cross-functional teams, manage complex technical programs, and mentor engineering staff.
  • Experience shaping process strategy, influencing technical direction, and contributing to long-term operational planning.

Technical Skills

  • Expert-level understanding of process engineering fundamentals, mass/energy balances, process control, and equipment design.
  • Strong ability to develop, interpret, and approve P&IDs, engineering drawings, and automation logic.
  • Advanced data analysis and modeling capabilities using engineering and statistical tools.
  • Excellent communication, leadership, and program management skills.
  • Ability to manage multiple high-priority initiatives in a fast-paced, technically demanding environment.

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.

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Syner-G BioPharma Group

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Syner-G BioPharma Group (operating under synergbiopharma.com) is a leading global provider of integrated scientific, technical, regulatory, and compliance consulting services for the pharmaceutical, biotechnology, and medical device industries. Founded in 2007 by seasoned pharmaceutical scientist Dr. Prabu Nambiar, the company operates as a premier strategic development and delivery partner, guiding innovators through the complex multi-phase drug development lifecycle from pre-clinical Investigational New Drug (IND) milestones to post-approval commercialization. Syner-G's core architecture revolves around its proprietary CMC 360™ framework, an end-to-end technical offering covering Chemistry, Manufacturing, and Controls (CMC) technical operations, regulatory affairs strategy, medical writing, and rigorous cGxP quality compliance. The company operates a functional outsourcing and strategic advisory model, partnering closely with clients to apply Quality by Design (QbD) principles and build seamless operational bridges with Contract Development and Manufacturing Organizations (CDMOs) across small molecules, large molecule biologics, cell and gene therapies, and advanced virology programs. Backed by a growth equity investment from Boston-based private equity firm Riverside Partners, Syner-G has expanded its international delivery capacity significantly through targeted integrations, including the acquisitions of Sequoia Biotech Consulting and RMC Pharmaceutical Solutions. Further driving innovation, in mid-2026 the firm launched 3D Intelligence (3Di), a people-centered artificial intelligence transformation service tailored specifically to streamline biopharma documentation and development workflows. Consistently recognized by BioSpace as one of the industry's premier workplaces, the organization is headquartered in Framingham, Massachusetts, and leverages a global, distributed network of over 400 specialized bio-pharmaceutical consultants, engineers, and regulatory compliance strategists across North America, Europe, and the Asia-Pacific region.

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Principal Process Engineer at Syner-G BioPharma Group