Job Reference: frs61711
Job Duration:
Start date: 01/08/2024
Description:
Site Microbiologist- Projects
I am excited to announce a new opening for a Site Microbiologist for a cutting-edge biopharmaceutical manufacturing facility. If you have a passion for microbiology and a proven track record in maintaining high standards in cleanroom environments, I want to hear from you!
The role will involve managing a project to upgrade cleanroom environments from Grade D to Grade A classification
RESPONSIBILITIES
* Lead and manage a project to upgrade certain cleanroom environments from Grade D to Grade A classification.
* Develop and implement a detailed action plan, including timelines, resource allocation, cost, and risk management strategies.
* Ensure all microbiological practices comply with GMP and any other relevant regulations.
* Conduct regular audits and inspectionsto maintain high standard of cleanliness and sterility and bioburden control.
* Design and implement robust environmental monitoring programs for the upgraded cleanrooms.
* Analyse environmental monitoring data, identify trends, and take corrective actions, as necessary.
* Lead aseptic process simulation (APS's) qualification activities as per the guidance of Annex 1 for newand existing equipment that is required to support aseptic processing in the upgraded cleanrooms.
* Develop and execute aseptic process simulation validation protocols and generate comprehensive aseptic process simulation validation reports.
* Experience with validation and qualification of manufacturing equipment, HVAC systems, and other critical systems in a GMP environment.* Draft, review, and update SOPs related to microbiological practices, cleanroom operations, and environmental monitoring.* Coordinating on site aseptic processing and gowning training and implement routine requalification program.
* Implement andmaintain effective contamination control strategies to prevent microbial contamination in the manufacturing process.
* Investigate and resolve microbiological deviations and non-conformities.
* Collaborate with Operations, Quality, Engineering and TSAto ensure microbiological quality throughout the manufacturing process.
* Ability to identify potential environmental, health,and safety hazards in the microbiological lab and manufacturing environments.
* Requirements
* At least 5 years of experience in a similar role, preferably in a biopharmaceutical manufacturing setting.
* Extensive expertise in cleanroom validationand qualification processes.
* Proven experience managing and coordinating environmental monitoring programs.
* Prior experience with cleanroom classification upgrades is highly desirable.
* Familiarity with regulatory, client inspections, and audits.
* Advanced proficiency in MS Excel, Word, and PowerPoint.
* Fluent in both written and spoken English.
* In-depth knowledge of GMP regulations and guidelines.
* Specific knowledge of aseptic process simulations, cleanroom qualifications and deepunderstanding of Annex 1 guidance.
* Expertise in microbiological testing, environmental monitoring and contamination control.
* Excellent project management and organisational skills.
* Strong leadership skills - this role requires leading a multidisciplinary team to achieve Grade A classification.
* Excellent problem solving, analytical and decision-making abilities, particularly to trouble shoot and address microbiological deviations and non-conformities.
* Ability to prioritise workload and set direction.
* Strategic thinker with proven ability for forward planning.
* Strong communication and interpersonal skills.* Flexible and agile in support of site's overall mission.
Why this Site Microbiologist Job?
* Be part of a team dedicated to innovation and quality in biopharmaceutical manufacturing.
* Work on a variety of impactful projects
* Collaboratewith industry experts in a supportive, growth-oriented environment.
* Support with further education /training
* Hybrid workoption after completion of probationary period
Ready to take the next step in your career? Apply now
Keywords: Microbiologist ,GMP Micro, Microbiologist Job Sligo QA Microbiologist Job Sligo Microbiologist Job
Industry: Pharmaceuticals
Salary: €60000 - €62000 per annum + Benefits
Salary Benefits: Benefits
Vacancy Type: Permanent
Job Skills: Microbiologist, Site Microbiologist , QC Micro Analyst
Contact Name: Felicity Farrell
Website: -
Direct Application URL: -