Sr. Fill Finish Process Engineer (Future Opportunities)

Initial Therapeutics, Inc.; California (MO); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Market competitive base salary

Flexible paid time off

Remote work options

Job summary

Initial Therapeutics, Inc. is seeking a Sr. Fill–Finish Process Engineer to join our team in California. This role involves supporting the capital project buildout of a new fill–finish suite within a commercial pharmaceutical manufacturing facility.

The ideal candidate should possess strong experience in aseptic pharmaceutical manufacturing, along with expertise in formulation, sterilization processes, and GMP operations. This position includes collaboration with cross-functional teams to ensure compliance and continuous improvement in manufacturing processes.

Qualifications

• 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 with commissioning and qualification documentation.

Responsibilities

• Support design and qualification of a new commercial fill–finish suite.
• Contribute to user requirement development and equipment specifications.
• Serve as subject matter expert for fill–finish operations.

Skills

Aseptic operations

Technical writing

Problem-solving

Multiple priorities management

Communication skills

Education

Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or related

Tools

Building management systems

Computerized maintenance management systems

KNEAT digital validation platform

Job description

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.

We are actively seeking qualified candidates to join our talent pipeline for future client engagements.

WORK LOCATION

Travel to client sites may be required up to 100% based on project phase and client needs.

KEY RESPONSIBILITIES

• 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, PIDs, 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 the validated state of aseptic manufacturing processes.
• Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.
• Support continuous 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.

PHYSICAL DEMANDS

Lifting and carrying objects up to 25 pounds, walking, sitting, standing, and using computer keyboard and mouse are regularly required.

WORK ENVIRONMENT

The work environment includes moderate noise, an indoor temperate environment, bright lighting, and typical office conditions.

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 enjoy a generous flexible paid time off program, company‑paid holidays, flexible working hours, and remote work options for most positions. Physical work locations include Greater Boston, San Diego, CA, Boulder, CO, and India.

LEGAL STATEMENT

Syner-G is proud to be an Equal Employment Opportunity and affirmative action employer. All employment decisions, including 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 is an E-Verify employer.

VISA SPONSORSHIP

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment visa at this time.