Desired Skills: Single Use Technologies,process scientist,batch records,ADC manufacturing,Process Transfers,upstream processing,GMP Compliance
Top skills:
- Knowledge of Single-Use Technologies: Understanding single-use systems such as bioreactors, mixing systems, tubing, and connectors used in biopharmaceutical processes. Experience in design of single use assemblies for new projects
- GMP Compliance and Documentation: Experience working in a Good Manufacturing Practice (GMP) environment, including proper documentation, batch records, and adherence to quality and regulatory standards.
- Equipment Setup and Troubleshooting: Hands-on skills for setting up, operating, and troubleshooting single-use equipment and related process systems.
- Communication and Teamwork: Effective communication skills to interact with cross-functional teams and the ability to train or mentor others in single-use system operations.
- Previous experience in ADC manufacturing facilities
- Previous experience process transfer in GMP manufacturing facilities
- Experience in cleaning study design
- Experience in upstream processing, UFDF, mixing, single use, chromatography
- Working in team exposure and capacity to influence decision making
Responsibilities:
- Performing gap analysis, facility fit studies, process safety and risk analysis for NPI.
- Monitoring and analysis of process data during the manufacturing.
- Assisting in the development of the manufacturing process for new products.
- Providing operational technical support for process related issue resolution.
- 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:
Essential Requirements
- Third level degree in a relevant engineering, science or technical discipline required.
Desired Requirements
- 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.
Technical/Business Knowledge -Job Skills/Experience Required
– 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
- Every employee has a personal responsibility to commit to our company vision, to engage and align with the Strategic Imperatives, and to consistently execute in accordance with the company Operational Pillars and our Ways of Work.
– 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.
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.
Please click the link below to apply or alternatively send an up-to-date CV to howie.leahy@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
Contract 
Sligo, County Sligo, Ireland 
42087760 
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