POSITION OVERVIEW:

We are seeking an experienced Sr. Process Engineer to support the development and implementation of a comprehensive terminal sterilization program. This individual will play a critical role in establishing the technical and operational framework for sterilization processes that ensure product safety, regulatory compliance, and manufacturing readiness. The ideal candidate brings deep technical expertise in terminal sterilization methods, strong program development experience, and the ability to collaborate cross-functionally with CQV, engineering, and operations teams to design, implement, and execute robust sterilization solutions.

WORK LOCATION:

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

KEY RESPONSIBILITIES:

• Develop and document detailed sterilization process flow diagrams and program architecture
• Define sterilization recipes, cycle parameters, and operating ranges
• Establish overall sterilization program strategy, standards, and best practices
• Partner with CQV, engineering, and manufacturing teams to support execution and implementation
• Lead troubleshooting and technical problem-solving during cycle development and start-up
• Support commissioning, qualification, and validation activities (protocol development, execution support, deviation resolution)
• Ensure compliance with GMP, FDA, and regulatory requirements
• Provide subject matter expertise and training to operations staff
• Drive readiness for manufacturing operations and sustainable long-term performance

QUALIFICATIONS & REQUIREMENTS:

Education:

• Bachelor's degree in Engineering, Life Sciences, or related technical field 5+ years of experience in pharmaceutical/biotech or medical device manufacturing environments

Technical Experience:

• Demonstrated hands-on expertise with terminal sterilization technologies (e.g., steam, EO, dry heat, or other validated methods)
• Experience designing and implementing sterilization programs or systems at a site or program level
• Experience supporting new facility start-ups or program build-outs

Knowledge, Skills, and Abilities:

• Working knowledge of CQV, validation, and GMP compliance standards Strong documentation, technical writing, and cross-functional collaboration skills
• Background in process engineering or validation leadership Familiarity with regulatory inspections and audit readiness
• Ability to influence stakeholders and lead multi-disciplinary teams

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.