Associate MSAT Engineer

Principal Responsibilities

• Support cross-functional collaboration with sponsors, R&D, Quality, Supply Chain, Engineering, and Safety teams to design and implement new equipment, processes, and technologies in support of GMP manufacturing.
• Support technology transfer activities for new and existing products, ensuring seamless transition from R&D into GMP manufacturing facilities.
• Author and review key technical and GMP documentation, including user requirement specifications, risk assessments, system classifications, validation protocols (IQ/OQ/PQ), SOPs, batch records, training materials, and logbooks.
• Support manufacturing operations throughout the product lifecycle, providing technical expertise and troubleshooting for equipment, processes, and deviations.
• Support and deliver training programs to ensure staff competency in equipment operation, aseptic techniques, and process execution.
• Partner with Quality Assurance on investigations, deviations, CAPAs, and root cause analyses, ensuring regulatory compliance and timely resolution.
• Identify and optimize production efficiency and facility capability through process improvements, material workflows, and facility/room layout enhancements.
• Collaborate with Supply Chain and Engineering to ensure timely availability of consumables, spare parts, and equipment required to meet production and sponsor requirements.
• Provide SME support for regulatory inspections, audits, and sponsor interactions.
• Champion safety, compliance, and continuous improvement within MSAT and across manufacturing operations.

Qualifications & Requirements

• Bachelor’s degree in a STEM discipline (Chemistry, Engineering, Biology, or related field) required; advanced degree preferred.
• Minimum of 2 years’ experience in an FDA-regulated CGMP environment (21 CFR Parts 210 and 211 required).
• Demonstrated expertise in aseptic processing, radiopharmaceutical development, pharmaceutical formulation and regulated production of therapeutics.
• Hands-on experience with hot cell operations and industry-standard automated synthesis, dispensing, and packaging systems preferred.
• Strong technical writing skills with a proven ability to author validation protocols, SOPs, and other cGMP documentation.
• Mechanical aptitude and strong problem-solving skills with the ability to provide frontline troubleshooting of equipment and processes.
• Experience leading technology transfer projects and supporting manufacturing operations at a senior technical level.
• Excellent communication, interpersonal, and collaboration skills with the ability to influence and work effectively across functions and with external partners/sponsors.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities in a fast-paced environment.
• Proficiency with Microsoft Office Suite and related software.
• Ability to travel up to 25% as business needs require.