[Hiring] Process Engineer @Syner-G

Role Description

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

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

Requirements

• 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.
• 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

• 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.

Benefits

• Market competitive base salary and annual incentive plan.
• Robust benefit offerings.
• Ongoing recognition and career development opportunities.
• Generous flexible paid time off program.
• Company-paid holidays.
• Flexible working hours.
• Fully remote work options for most positions and the ability to work “almost anywhere.”
• Office locations in 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 the 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.