Req ID: R0023048
, Meath IE
Posted Date: December 5, 2018
As our successful Plant Microbiologist you will support the Microbiology Laboratory Start-up activities and will function as the site Microbiology Subject Matter Expert (SME) at the new single use multi-product biotech facility in Dunboyne, County Meath, Ireland.
The overall responsibility for this role will be to support the Microbiology Quality Control testing function, ensuring compliance with cGMP and corporate regulations. This is a critical role within the Quality organisation to help establish the Laboratories as a hub for specialised analytical testing and create value for our patients.
Essential Duties and Responsibilities
- Responsible for the Microbiology Laboratory Start-up activities which includes development of User Requirements Specifications (URSs), Risk Assessments, Protocols, Reports, Standard Operating Procedures (SOPs), work instructions, procurement and qualification of laboratory equipment.
- Provide technical support for the qualification and validation of the manufacturing and warehouse areas, which includes Facility, Equipment, Environmental Monitoring program, Process Validation and Continued Process Verification (process monitoring).
- Assist in the establishment of the Microbiology team supporting the technical transfer of products through to operation readiness: Method Transfer/Validation, Contamination control strategy, Aseptic training, Environmental Monitoring program, raw materials testing, product testing, in-processing testing, process validation and facility validation.
- Responsible for the operation and inspection readiness of the Microbiology laboratory by ensuring the laboratory operates in compliance with current Good Laboratory Practice / Good Manufacturing Practice at all times.
- Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
- Manage the site Environmental Monitoring program to support the manufacturing activities on site.
- Lead and participate in the technical transfer / validation of microbiological testing procedures.
- Oversee the management of the contract testing laboratories associated with microbiological testing.
- Oversee the management of Laboratory investigations into any non-conformance, instrument malfunction, accident or other abnormal occurrence.
- Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per local site SOP.
- Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate, customer).
- Actively lead and support projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
- Implement and maintain standards of safety to ensure a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe at all times.
- Generate, implement and control of Microbiology annual budget for consumables, capital and headcount.
- Participate, as required, in global project teams relating to Microbiology and wider quality activities.
Education and Experience Requirements
- A minimum of a Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, engineering).
- A minimum of 8 years’ experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company, at a supervisory/Managerial level
- Extensive experience of microbiology testing
- Previous experience in start-up projects
- An understanding of cGMP requirements for manufacturing and/or systems and compliance.
- An understanding of GMP, ICH, USP and global compendia regulations and guidance’s, particularly as related to analytical method development and validation.
- Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMIAC, Lean QA, 5S etc).
Key Skills, Abilities, and Competencies
- Excellent trouble shooting and problem solving skills.
- Ability to challenge the status quo with a continuous improvement mindset.
- Promoting a culture where diversity and inclusion is part of the DNA.
Complexity and Problem Solving
- Identifying and communicating risks in area of responsibility and across the site.
- Creating strategies and plans to manage risk within the Quality Control operation.
Internal and External Contacts
- For product quality, collaborates with Process Development Technical Services (PDTS) and Manufacturing Operations but is responsible for providing information to support the QMR decision.
- For quality and compliance, collaborates with the QMR but accountable for creating a ‘right first time’ culture in the Quality Assurance group to support quality excellence.
- For safety, the individual is accountable to drive a culture of ‘everyone owns safety’ with input from the EHS lead.
- For continuous improvement collaborates with Business Excellence peers across the Biologics business unit in Shire and through external forums to drive business excellence in Quality Assurance.