Manufacturing Process Specialist
Located at our site in Barnahely, Cork, this position requires a minimum of 3 days on-site work per week.
This 12-month contract role offers 39 hours of work per week.
The successful candidate will report directly to the Operations Manager and be responsible for representing operations on capital project teams.
The primary responsibilities of this role include:
1. Representing operations on cross-functional project implementation teams.
2. Monitoring and troubleshooting of the manufacturing process and equipment issues, with a focus on process optimization.
3. Monitoring and reporting of process performance using statistical process control.
4. Troubleshooting of DCS (e.g., Delta V) and PLC control systems.
5. Investigating and resolving issues raised within the Manufacturing Department.
6. Participating in or leading Cross-Functional teams as required.
7. Supporting commissioning and qualification activities.
8. Preparing and updating batch records, procedures, and work instructions.
9. Providing process and equipment-related training as required within the Manufacturing Department.
10. Ensuring the completion of assigned tasks to support the manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
Roles and Responsibilities
1. To lead by example and strive to perform to high standards at all times.
2. Responsible and accountable for assuring the safe accomplishment of job activities, following good environmental practices and procedures. Commit to and demonstrate safe behavior in every activity.
3. To carry out routine and non-routine tasks delegated by the Operations Manager according to appropriate procedures, values, and standards.
4. To carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.
5. Compliance with Manufacturing and general site procedures at all times.
6. Completion of all documentation in compliance with site procedures and GDP.
7. Execution of activities as necessary to meet operational and business needs.
8. To lead, support, and participate in commissioning and qualification activities both current and future projects (and annual re-qualification activities). Also, support validation activities.
9. Prioritize and schedule activities to support business needs and to meet requirements of Master Production Schedule.
10. Lead and Support investigation and resolution of problems on plant.
11. Participate in and lead Cross-Functional teams as necessary.
12. Generate and assist with generation, review, and revision of Manufacturing documentation as necessary.
13. Ensure that personal training requirements are completed in compliance with site procedures. Training and support for new recruits to the Manufacturing group.
14. Support ongoing studies by Validation, OTS, and other support functions.
Requirements for Success
The ideal candidate will possess the following qualifications:
1. A relevant third-level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science, or Engineering.
Desirable Qualifications
The following qualifications are highly desirable:
1. Manufacturing experience within a GMP-regulated environment.
2. Experience of the cell culture or purification processes.
3. Project/New equipment installation experience.
4. Process engineering experience.
5. Commissioning and qualification experience.
6. Postgraduate Qualification.
7. Experience of Microsoft Word, Excel, and Outlook.
8. Experience of DCS (e.g., Delta V), SCADA, and PLC systems.
9. Experience of SAP, LIMS, and/or other business systems.
10. 6-Sigma/Kepner-Tregoe or similar problem-solving/decision-making methodology training.
Key Competencies Required
The successful candidate will possess the following key competencies:
1. Excellent interpersonal skills.
2. Ability to operate as part of a team is critical.
3. Customer focus.
4. Innovative.
5. Mechanical/Technical aptitude.
6. Excellent communication skills both written and verbal.
7. Attention to detail.
8. Good problem-solving skills.
9. Results and performance driven.
10. Adaptable and flexible.
Benefits
This role offers a competitive hourly rate and has a strong chance of extension beyond the initial 12-month contract period.