Senior Engineering Specialist

Mariana Oncology • Watertown, MA

4d • Onsite

About The Position

We are seeking a proactive Senior Engineering Specialist to join Mariana’s Manufacturing Science & Technology organization, advancing personalized medicine and radiopharmaceuticals. This person will support operations at both new and existing facilities for the clinical manufacturing of sterile radiopharmaceuticals. This role is responsible for the execution of engineering activities — including design, implementation, and maintenance — within an FDA cGMP environment, using reliable and cost-effective technical solutions to meet overall site and project objectives. The Engineering Specialist ensures that all operations meet efficiency, safety, and regulatory requirements, and will support the expansion of the site’s electronic qualification and calibration systems to a new facility. Illustrative Breadth of Responsibilities: Compliance & Quality Adhere to applicable quality policies and procedures to ensure all products are safe, pure, effective, and of the highest quality. Ensure all facility operations comply with FDA cGMP regulations and applicable global standards Complete and maintain accurate documentation as required in cGMP operations. Serve as a cross-functional partner during audits and inspections; support investigations and deviations and help drive timely closure of deviations and CAPAs. Partner with site HSE to ensure that production suites meet safety requirements and local regulations. Maintenance & Engineering Operations Manage and perform preventive, corrective, and predictive maintenance on cGMP manufacturing systems and equipment. Troubleshoot and repair process equipment (e.g., containment isolator systems, filling line equipment, utility connections) covering mechanical, electrical, pneumatics, motors, pumps, vacuum systems, HVAC, control systems, and compressed gases — under little to no supervision. Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs. Support facility modifications, equipment installations, system upgrades, and startup/commissioning activities. Maintain and expand the calibration and maintenance plan for the GMP portions of the facility/campus. Safety & Radiation Programs Implement and uphold safety protocols to maintain a secure working environment. Wear and work in protective clothing as required, possibly including respiratory protection, confined space entry equipment, and cleanroom PPE. Documentation & Reporting Develop, maintain, and train personnel on Standard Operating Procedures (SOPs) and training documents related to facility and utility systems in relation to production and laboratory equipment. Maintain accurate records of maintenance activities, inspections, and compliance reports. Prepare technical reports evaluating trends and facility performance data; supply information and technical data for securing spare parts. Team Leadership & Collaboration Provide guidance, leadership, and training to less experienced maintenance technicians and new team members. Support 24/7 site-based operations after startup; flexibility to work nights, weekends, and holidays as required. Perform other related duties as assigned.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, or a related field is preferred.
• Minimum 3 years of relevant hands-on plant maintenance experience in an FDA cGMP-regulated environment; pharmaceutical, radiopharmacy, or medical device manufacturing preferred.
• Strong knowledge of FDA, ICH, EU, and UK regulations as they apply to manufacturing facilities.
• Familiarity with good lab safety practices and local regulations.
• Demonstrated ability to manage multiple tasks under tight timelines with meticulous attention to detail.
• Effective oral and written communication skills; ability to work collaboratively across cross-functional teams.
• Proven ability to work independently and lead tasks or small teams through to completion.
• Problem-solving mindset with the ability to own processes end-to-end.
• Technical report writing and documentation proficiency.
• Familiarity with Blue Mountain RAM or similar CMMS; proficiency in MS Office suite and Building Management Systems.
• Occasional lifting of 35+ pounds.
• Vision correctable to 20/20.
• Comfort measuring and mixing precise amounts of liquid and/or material(s).
• Able to stand for long periods.
• Able to work in a cleanroom for long periods.

Nice To Haves

• Previous experience in aseptic fill/finish and/or radiopharmacy operations is preferred.

Responsibilities

• Adhere to applicable quality policies and procedures to ensure all products are safe, pure, effective, and of the highest quality.
• Ensure all facility operations comply with FDA cGMP regulations and applicable global standards
• Complete and maintain accurate documentation as required in cGMP operations.
• Serve as a cross-functional partner during audits and inspections; support investigations and deviations and help drive timely closure of deviations and CAPAs.
• Partner with site HSE to ensure that production suites meet safety requirements and local regulations.
• Manage and perform preventive, corrective, and predictive maintenance on cGMP manufacturing systems and equipment.
• Troubleshoot and repair process equipment (e.g., containment isolator systems, filling line equipment, utility connections) covering mechanical, electrical, pneumatics, motors, pumps, vacuum systems, HVAC, control systems, and compressed gases — under little to no supervision.
• Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs.
• Support facility modifications, equipment installations, system upgrades, and startup/commissioning activities.
• Maintain and expand the calibration and maintenance plan for the GMP portions of the facility/campus.
• Implement and uphold safety protocols to maintain a secure working environment.
• Wear and work in protective clothing as required, possibly including respiratory protection, confined space entry equipment, and cleanroom PPE.
• Develop, maintain, and train personnel on Standard Operating Procedures (SOPs) and training documents related to facility and utility systems in relation to production and laboratory equipment.
• Maintain accurate records of maintenance activities, inspections, and compliance reports.
• Prepare technical reports evaluating trends and facility performance data; supply information and technical data for securing spare parts.
• Provide guidance, leadership, and training to less experienced maintenance technicians and new team members.
• Support 24/7 site-based operations after startup; flexibility to work nights, weekends, and holidays as required.
• Perform other related duties as assigned.

Benefits

• US-based eligible employees will receive a comprehensive benefits package that includes a strong health insurance package, life insurance, disability benefits, a 401(k) with company contribution and match, tuition reimbursement, and a variety of other benefits.
• In addition, employees are eligible for a generous flexible time off program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level