Senior Manufacturing Bioprocess Associate
Innopharma Technical Services, part of Innopharma Group, is seeking a Senior Manufacturing Bioprocess Associate to provide support to our multinational Biopharmaceutical client site based in Dublin.
About the position:
The Senior Manufacturing Bioprocess Associate (BPA) is responsible for executing and supporting all procedures associated with the manufacture of Drug Substance within a single-use biopharmaceutical manufacturing facility. This role ensures operations are carried out to the highest standards of Safety, Quality, and Compliance in a regulated GMP environment.
This is a site-based shift role within a high-performing manufacturing team, focused on delivering safe, compliant, and reliable production of sterile biologics. The role involves operating and monitoring process equipment, maintaining cleanroom and materials standards, supporting troubleshooting and maintenance activities, and contributing to investigations and continuous improvement initiatives.
The ideal candidate demonstrates a growth mindset, a “right-first-time” approach, strong ownership, and the ability to thrive in a fast-paced GMP manufacturing environment.
Key Responsibilities:
- Execute and support manufacturing and production operations, including assembly, processing, equipment operation, and packaging activities in accordance with GMP requirements.
- Develop and execute production schedules based on product demand, equipment availability, material readiness, staffing levels, and operational capacity.
- Perform all required preparatory, in-process, and finishing activities in line with regulatory requirements and site procedures.
- Operate within classified cleanroom environments, ensuring adherence to validated and qualified manufacturing processes.
- Support end-to-end production operations across both Fed-Batch and Continuous Manufacturing platforms.
- Operate and monitor equipment in accordance with Electronic Batch Records (EBR), sampling plans, and Standard Operating Procedures (SOPs).
- Support the authoring and revision of EBRs, SOPs, work instructions, and sampling plans as required.
- Participate in troubleshooting activities and contribute to root cause investigations and corrective actions.
- Maintain strict adherence to site safety, quality, and compliance standards at all times.
- Work collaboratively as part of a cross-functional process team, demonstrating flexibility and strong teamwork.
- Support manufacturing operations, including occasional weekend or out-of-hours work as required.
- Contribute to continuous improvement initiatives to enhance process efficiency, reliability, and compliance.
- Operate with minimal supervision, demonstrating strong technical competence and independent decision-making.
Preferred Experience:
- Level 7 qualification in a Science, Engineering, or related discipline is desirable.
- Level 6 qualification with a minimum of 3+ years’ experience in a GMP manufacturing environment may be considered equivalent.
- Strong troubleshooting and practical problem-solving skills within a regulated manufacturing setting.
- Proven ability to work independently and collaboratively in a cross-functional team environment.
- Working knowledge of contamination control principles and batch release requirements.
- Understanding of upstream and downstream unit operations in monoclonal antibody (mAb) manufacturing.
- Familiarity with both batch and continuous bioprocessing systems.
- Experience with automation systems such as Emerson DeltaV and PAS-X.
- Experience working in single-use technology environments, preferably end-to-end single-use facilities.
- Exposure to commissioning and qualification (C&Q) activities is advantageous.
- Flexible approach to shift work and site-based operational requirements.
Note:
- Due to the nature of the business, additional duties may be assigned from time to time.
- All applicants must be eligible to work in Ireland.
- All applicants must be willing to work in shifts.
Apply Now
If you’re passionate about manufacturing excellence and eager to grow in a fast-paced, regulated environment, we want to hear from you. Please send your CV to: [email protected]
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