15364181 – Equipment Process Specialist – Dublin Contractor

Responsibilities

This is a 12 month contract

• Generation of URS’s for process and analytical equipment.
• Support ongoing queries in relation to equipment selection.
• Support selection and preparation of procurement details for lab chemicals, reagents, and consumables, with the creation of bill of materials.
• Perform and input to risk assessments while partnering with MSAT team.
• Support CQV with the commissioning and qualification of equipment.
• Interact with vendors to support queries.
• Support the readiness for technology transfer of lab models and associated analytical method transfers.
• Create and track metrics, dashboards, schedules, project timelines, booking and facilitating meetings.
• Create and implement systems for the labs.
• Generate master lists for equipment and materials.
• You will work closely with team members of the MSAT Labs in the areas of cell culture, purification and analytical, project team, CQV and other functions in this new, exciting, MS&T labs start-up.
• Provide technical and user requirements in support of the design, fit out and start up of the MSAT Labs.
• Support technology transfer and lab operational readiness.
• Collation of data to generate metrics including project timelines.
• Setup and facilitation of meetings with cross functional groups.
• Generation, and maintenance of project documentation, material specifications, and SOPs/Logbooks.
• You will bridge efficient communication and decision making related to the technical requirements for the project.
• Engage with the business to map and plan out lab model and analytical method technology transfers, timelines and requirements.

Minimum Qualifications and Experience

• A degree in Life sciences or engineering subject area with experience in (bio)pharmaceutical manufacturing/development/process engineering/lab start up or operations with 8+ years.
• Excellent communication skills with the ability to successfully influence across levels, across functions, with senior leaders and technical leaders.
• Ability to work in a complex, dynamic, global environment, thinking strategically and balancing both long and short-term priorities
• The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry items in accordance with manual handling principles; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
• Experience of lab start-ups or similar.
• Experience in project management.
• Experience of lab start-up, including commissioning and qualification of small-scale process and analytical equipment.
• Familiar with raw materials and consumables.
• Experience of the set-up and operation of equipment sets such as small-scale bioreactors, associated small scale equipment, AKTA systems, and analytical equipment is beneficial.