Director, Manufacturing Technology & Process Engineer

Description

SHINE SPECT is seeking a Director of Manufacturing Technology & Process Engineering who will be responsible for leading all technical functions supporting radiopharmaceutical manufacturing at SPECT, including MSAT, process engineering, equipment/utility engineering, maintenance programs, and technical troubleshooting in support of automated manufacturing lines.

This leader ensures process robustness, equipment reliability, regulatory compliance, and continuous improvement in a high stakes, highly regulated environment. The Director of Manufacturing Technology & Process Engineering also owns technology transfer and technical readiness for new or modified processes.

The base salary range for this position is $200,000 - $230,000 per year plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location.

• Lead MSAT, process engineering, and equipment/utility engineering teams.
• Own process automation performance, equipment reliability, and technical support for manufacturing operations.
• Oversee troubleshooting and root cause analysis for process and equipment related issues.
• Implement and optimize CMMS programs, maintenance strategies, and equipment lifecycle plans.

• Provide scientific leadership in process development, scale up, optimization, and validation.
• Develop and implement control strategies, DOE studies, FMEA, and process risk assessments.
• Lead technology transfer activities for new products, equipment, and systems.

• Ensure all technical activities comply with cGMP, FDA, NRC, and quality expectations.
• Partner with Quality on deviations, CAPAs, investigations, and inspection readiness.
• Author and support key CMC documentation and regulatory submissions.

• Work closely with Manufacturing, Supply Chain, Engineering, EHS, and Quality to support smooth, reliable operations.
• Collaborate with external partners, vendors, and CDMOs on technical issues and technology transfer.

• Lead and develop a multidisciplinary team of engineers and technical staff.
• Build a technical talent pipeline to support long term operational sustainability.

• Drive continuous improvement initiatives to enhance efficiency, stability, and compliance.
• Champion digital and automation upgrades across manufacturing technology systems.
• Identify systemic issues and implement long term corrective actions.

• Bachelor’s degree in Engineering, Chemistry, or related discipline required.
• Advanced degree preferred.
• 10–12+ years in pharmaceutical, radiopharmaceutical, or highly regulated technical operations.
• Demonstrated leadership in MSAT, process engineering, or manufacturing technical services.
• Experience with equipment systems, utilities, CMMS, and troubleshooting.
• Strong experience with cGMP, validation, and regulatory expectations.
• Strong technical depth with ability to mentor and develop engineers.
• Excellent analytical, root cause, and problem solving capabilities.
• Strong communication skills for cross functional and regulatory interactions.
• Ability to translate legacy system knowledge into modernized technical frameworks.

• Ability to remain in a stationary position (e.g., standing or sitting) for extended periods.
• Ability to move within facility environments, including accessing testing areas and operating instrumentation.
• Ability to handle standard equipment and materials weighing up to 50 pounds with or without reasonable accommodation.
• Work may occasionally take place in controlled radiation areas under supervision and within regulatory exposure limits.
• Use of personal protective equipment (PPE).
• Work involves moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, smoke, unpleasant odors, and/or loud noises.
• Work environment involves some exposure to hazards or physical risks, which require following basic safety precautions.
• Although flexible work hours may be available, shift-work schedules may be required, and extended hours will sometimes be necessary to complete required work assignment.

Employees must be able to perform the essential functions of the position satisfactorily. If requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship.

SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions.

SHINE Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,…