The Project / Equipment Engineer reports to the Senior Manager for Engineering Projects and delivers engineering projects supporting Drug Product manufacturing, with a primary focus on lyophilisation and additional support across formulation, component preparation, filling, and inspection.
Responsibilities include implementing and qualifying new or upgraded equipment and establishing related maintenance and reliability programs.
Key Responsibilities Lead and deliver engineering projects, managing scope, priorities, resources, timelines, and internal/external communications across the full project lifecycle.
Collaborate with cross-functional stakeholders and system owners to define requirements, introduce new or upgraded processes and equipment, and resolve issues through commissioning, qualification, and start-up.
Develop and maintain engineering documentation, specifications, SOPs, change controls, and contribute to root cause and cross-functional investigations.
Establish and optimize maintenance strategies, spare parts management, and equipment reliability programs, including upgrades and retrofits with maintenance teams and vendors.
Ensure full compliance with GMP, company policies, and EHS requirements while supporting safe operations and participating in site and multi-site teams, including travel for project execution (e.g.
FAT).
Key Requirements Bachelor's degree in Mechanical, Electrical, or Chemical Engineering (or equivalent experience) with 3+ years' engineering experience in a GMP biopharmaceutical environment.
Proven project management capability with strong hands-on mechanical and equipment experience in technical roles.
Experience working in GDP-compliant environments, including change control and document management systems; proficient in MS Office and MS Project.
Strong cross-functional collaboration and leadership skills, with a track record of delivering technical solutions and continuous improvements.
Excellent communication, technical writing, and presentation skills, with a data-driven mindset and ability to perform under tight deadlines.
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