Operations Manager

Arcadis DPS are seeking an Operational Readiness Lead to join a new fill finish facility as it moves from construction into full scale production.

Position Summary : The facility will feature high-speed syringe filling lines, formulation, component prep, and inspection capabilities.

We are seeking an Operation Readiness Lead to play a pivotal role in ensuring "right-first-time" and "on-time" start-up readiness.

The Operations Readiness Lead will help shape the manufacturing landscape by developing and implementing robust processes, systems, and readiness activities.

Key Responsibilities : Lead cross-functional planning and execution of the Operations Readiness roadmap, from facility design through to PPQ (Process Performance Qualification).

Collaborate with capital project team as well as site operations functions such as engineering, quality, process development and EHSS teams to design and lead various operational readiness workstreams such as optimal material and process flows, materials requirements for testing and qualification activities, documentation such as operating philosophy that serve as inputs to detailed design of facility and equipment etc for a new aseptic facility Develop and maintain a readiness timeline identifying key milestones, dependencies, and resource needs.

Able to perform and lead Gap analysis documentation on site and network practices and drive any mitigation actions to close the gaps.

Facilitate risk assessments and mitigation strategies tied to operational readiness and manufacturability Coordinate and lead the development of operational procedures, and batch records to support GMP-compliant, efficient start-up Serve as the voice of manufacturing operations within cross-functional start-up and tech transfer teams, bringing a practical, floor-focused lens to facility and process design Drive continuous improvement initiatives to optimize operational performance and reduce variability during start-up.

Basic Qualifications : 8+ years of experience in biopharma operations, with significant exposure to aseptic manufacturing, sterile drug product filling, and start-up or capital projects environments Proven ability to lead cross-functional teams and projects in a matrixed, fast-paced environment.

Strong knowledge of GMP regulations and practices particularly related to sterile fill-finish processes.

Excellent communication and organizational skills, with a demonstrated ability to self-start and manage ambiguity in a greenfield or brownfield setting.

Experience in developing and deploying SOPs, batch records, and training documentation.

Preferred Qualifications : Prior involvement in facility design, commissioning, or start-up of drug product operations.

Experience working with automation and high-speed filling lines for syringes Interested parties should forward a copy of their CV via the link below or contact Fergal Walshe via LinkedIn for further information Skills : Operations Management Drug Product Manufactuing Pharma pharmaceutical Science Fill Finish