NPI Process Scientist

Orion Group Life Sciences are currently recruiting a NPI Process Scientist on behalf of our Multinational Biopharmaceutical Client based in Sligo on an initial 12-Month contract with potential to extend.
 
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.
• 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

 
Cognitive Skills:

• The position requires proven problem-solving skills under pressure. The position requires detailed evaluation of a number of viable solutions to each problem.
• The position requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
• 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.
• Requires total commitment to quality while maintaining a high standard of work at all times.
• Demonstrates the highest levels of integrity and a strong work ethic at all times.
• Strong communication skills both verbal and written are required for the execution of this role.
• Strong interpersonal skills are required.
• Understands and supports the principles of Perfect Performance.
• Prioritises their own and their teams work in line with business demands.

 
Ownership/Accountability:

• The position has a high level of autonomy and individuals are expected to work on their own initiative.
• Supports and executes Commercial Product campaigns successfully.
• Supports successful introduction of NPI’s onsite.
• Partners with the EHS&E group on safety related tasks.
• Shows a high level of tenacity to ensure closure of issues.
• Demonstrates an ethos of Right First Time at all times.
• Ensuring team compliance to procedures, policies and guidelines ensuring adherence with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines as all times.

 
Influence/Leadership:

• May be required to support cross functional teams and cost improvement projects.
• Required to lead cross functional teams and cost improvement projects.
• Develops and maintains close relationships with MS&T and GPRD.
• Provide technical leadership to functional areas.
• Provide leadership in sub projects related to commercial or NPI activities.
• Must be able to influence leaders on system improvement projects.
• Contributes to the successful delivery of site CJRs and Goals.
• 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.

 
Decision Making/Impact:

• Expected to provide functional expertise to support daily operations.
• Seeks Managers input when making significant decisions which affect the area.

Supervision Received:

• Operates in an environment which is largely self-managed but with supervision through the NPI Technical Manager.
• Goals are reviewed on a regular basis

Supervision Provided:

• NPI process scientist can provide intermittent supervision and guidance to ODP, TDP or interns as required.

 
EHS Responsibilities:

• Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
• Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.
• Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in EHS system.
• Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system.
• Attend all required EHS training and medical surveillance programs.
• Wear PPE as required.

 


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Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.