Cork city, Ireland | Posted on 02/07/2025
* Industry: Pharma/Biotech/Clinical Research
* Work Experience: 4-5 years
* City: Cork city
* State/Province: Cork
* Country: Ireland
Job Description
About PSC Biotech
Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points, which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment giving exposure to working in top pharmaceutical client sites in a diverse cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech; we provide unparalleled empowering career development through Learning & Development in-house training mentorship, with constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations regarding the quality of all scalable and business unit deliverables, staying under budget, and ensuring timelines for our deliverables are being met.
Job Summary
* Reporting into the Snr Plant Microbiologist, the Operations Microbiologist is responsible for active participation in the microbiological control and assurance program within the operations department.
* Managing activities in compliance with corporate, cGMP, EHS, and other regulatory requirements.
The responsibilities:
* Lead by example and strive to perform to high standards at all times in compliance with Credo and Standards of leadership.
* Perform all activities in compliance with corporate, cGMP, EHS, and other regulatory requirements.
* Actively lead/support process microbiological investigations.
* Perform routine area walkdowns/GEMBA’s.
* Support and drive strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene through the promotion of a culture of continuous improvement and open communication.
* Perform Risk Assessments for operations projects and business innovation initiatives.
* Define specific aseptic techniques to be performed for crucial process steps.
* Support periodic review of environmental monitoring and in-process sampling trends and identify appropriate corrective and preventative actions as required.
* Provide effective and timely communication of any adverse trends or activities as appropriate.
* Achieve individual goals through actively working with departments and individuals.
* Maintain customer focus to deliver business requirements.
* Collaborate with Process Microbiologists internally and across the **** network.
* Access global microbiology support resources as required.
* Review and approve relevant SOPs and WIs.
* Participate in the planning for future requirements in Operations.
* Ensure microbiological control strategy is consistent with GMP requirements and company requirements.
* Participate in relevant internal and external manufacturing-related audits.
* Understand and support current regulatory trends and future testing requirements.
* Deputize for the Microbiology team as required.
* Comply with EHS rules and procedures at all times.
Requirements
We would love to hear from YOU if you have the following essential requirements:
ESSENTIAL:
* BSc in a scientific/technical discipline required. Ideally microbiology discipline.
* Minimum of 5 years of experience within a pharmaceutical or GMP regulated operations environment.
* Possess knowledge and experience of the shop floor manufacturing process.
* Possess knowledge of data analytics.
* Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
DESIRABLE:
* Validation experience within a Life Sciences or Biopharmaceutical manufacturing environment.
* Business Excellence and Problem Solving skills qualifications e.g. Six Sigma, Lean Green/Black Belt or Kepner-Tregoe analysis.
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