POSITION OVERVIEW:We are seeking a Sr. Fill-Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill-finish suite within a commercial manufacturing facility. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP operations and regulatory expectations. This position partners closely with operations, QA, validation, MS\&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance.
WORK LOCATION:Travel to client sites may be required up to 100% based on project phase and client needs.
KEY RESPONSIBILITIES:(This list is not exhaustive and may be adjusted as needed.)
- Support design, construction, installation, and qualification of a new commercial fill-finish suite, including cleanrooms, process utilities, and supporting infrastructure.
- Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
- Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
- Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P\&IDs, and GMP requirements.
- Serve as subject matter expert for fill-finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection.
- Partner with Operations and MS\&T to troubleshoot and resolve technical issues.
- Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
- Support continuous improvement and process optimization initiatives.
- Partner with QA, Validation, and MS\&T to maintain validated state of aseptic manufacturing processes.
- Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.
- Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring.
- Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports.
- Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages.
- Develop and execute commissioning and qualification protocols.
- Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus.
- Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines
- Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution.
- Participate in project planning, scheduling, risk assessments, and milestone tracking.
- Provide effective communication to stakeholders at all levels.
QUALIFICATIONS AND REQUIREMENTS:Education
- Bachelor's or Master's degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.
Experience
- Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
- Strong preference for sterile, aseptic, biologics, or vaccine fill-finish experience.
- Experience supporting commercial manufacturing operations in a regulated environment.
- Experience with commissioning, qualification, and engineering documentation.
Knowledge, Skills, and Abilities
- Strong understanding of aseptic operations, cleanroom environments, and fill-finish equipment.
- Strong documentation and technical writing skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Strong communication, analytical, and problem-solving skills.
- Ability to work independently and collaboratively.
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.
