NPI Process Scientist – Sligo

PE Global (UK); Sligo; On-site; EUR 60,000 - 80,000; Full time

Job summary

PE Global are currently recruiting for an NPI Process Scientist for our client site in Sligo on a 12-month initial contract. The role sits in Technical Operations and reports to the NPI Technical Manager.

The candidate will assist in developing manufacturing processes for new products, provide technical support, and lead risk assessments and documentation related to NPI. Collaboration with global science and quality teams is essential.

Qualifications

• Bachelor's degree in engineering/science or technical discipline required.
• 3 years’ experience in pharmaceutical process engineering with batch processing and tech transfers.
• 1 year in a similar role and 1 year within pharmaceutical or bio industries.
• Strong attention to detail and compliance with procedures at all times.

Responsibilities

• Develop manufacturing process for new products.
• Provide operational technical support for process issues.
• Perform gap analyses, facility fit studies, process safety and risk analyses for NPI.
• Monitor and analyse process data during manufacturing.
• Prepare and update specifications for NPI materials and consumables.
• Lead or assist risk assessments (e.g., PFMEA, EHS).
• Develop NPI documents (Transfer Plans/Protocols/Procedures/Manufacturing Batch Records).
• Collaborate with global science and quality teams on process development for future AbbVie products.
• Assist and/or lead product and process investigations and change plans.
• Support, supervise, and train operations personnel for NPI processes.
• Adhere to and support all EHS&E standards, procedures, and policies.

Skills

Pharmaceutical process engineering

Attention to detail

Results driven

Leadership

Education

Bachelor's degree in engineering/science

Master's degree desirable

Job description

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.