NPI Process Scientist - Sligo

PE Global are currently recruiting for a NPI Process Scientist f or our client site in Sligo on a 12-month initial contract:

NPI Process Scientist -

Dept: Technical Operations

Reports to: NPI Technical Manager

Responsibilities:

• Assisting in the development of the manufacturing process for new products.
• Providing operational technical support for process related issue resolution.
• Performing gap analysis, facility fit studies, process safety and risk analysis for NPI.
• Monitoring and analysis of process data during the manufacturing.
• Preparation and updating of specifications related to NPI materials and consumables.
• Lead and / or assist risk assessments (e.g., PFMEA, EHS).
• Development of NPI related documents e.g., Transfer Plans/Protocols/Procedures/Manufacturing Batch Records.
• Working closely with global science and quality teams, on the process development of suitable future products for AbbVie.
• Assisting and /or leading product and process related investigation and change plans.
• Supporting, supervising, and training operations personnel for NPI processes
• Adheres to and supports all EHS&E standards, procedures, and policies.

Requirements:

• Third level degree in a relevant engineering, science or technical discipline required.
• Masters Qualification in relevant technical discipline desirable.
• 3 years' experience in pharmaceutical process engineering, with relevant experience of batch processing, technical transfers, scale up, in a cGMP pharmaceutical or Biologics industry.
• Experience in new product introductions to Biologic facilities desirable.
• Minimum of 1 years in a similar type of role.
• Minimum of 1 years within Pharmaceutical or Bio Industries.
• Strong technical and operational knowledge of unit operation within a fill finish facility
• Requires a very high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
• Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
• Provide leadership in sub projects related to commercial or NPI activities.
• Leads the delivery of new Technical Operations initiatives.
• Promotes department goals by selecting, motivating, and training capable staff.
• Leads the activities of assigned staff by communicating and providing guidance towards achieving department objectives.
• Contributes to Talent Management of teams within the organisation and to the development of the team to meet evolving business needs
• Operates in an environment which is largely self-managed but with supervision through the NPI Technical Manager.
• Goals are reviewed on a regular basis
• NPI process scientist can provide intermittent supervision and guidance to ODP, TDP or interns as required.
• medical surveillance programs.