Microbiology and Contamination Control Manager Job at SRG (Falkirk)

Contamination Control Manager

At SRG, we are excited to be partnering with our client, a biologics Contract De...

Location

United Kingdom , Falkirk

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

Degree in Microbiology, Biology, Biochemistry, Chemical Engineering or related discipline (Master's preferred)
Extensive industry experience in sterile or biologics pharmaceutical manufacturing, ideally within a CDMO
Strong expertise in aseptic processing, cleanroom operations and microbiological contamination control
Proven experience leading FMEA and cross-functional risk assessments
Solid understanding of global regulatory expectations
Ability to influence in matrixed environments with strong communication, coaching and facilitation skills

Job Responsibility

Own and evolve the site Contamination Control Strategy in line with EU/UK GMP Annex 1, FDA and ICH expectations
Embed contamination control principles into facility and equipment design, process flows, cleaning and sterilisation strategies, supplier management and training programmes
Partner with Manufacturing to influence aseptic behaviours, shift routines, operator decision-making and capability development
Collaborate with MSAT across equipment design, tech transfer, scale-up, process characterisation and new product introduction
Ensure full integration of the CCS with Quality systems including deviations, investigations, CAPAs, change control and audit readiness
Lead contamination-focused risk assessments (including FMEA) across client processes, shared equipment, utilities, campaign manufacturing and changeovers
Translate risk into practical, executable operational controls and maintain assessments as living tools informed by data and trends
Design and deploy contamination control training tailored to a CDMO environment, reinforcing learning through hands-on coaching and on-the-floor engagement
Champion a strong site-wide contamination control culture where prevention is everyone's responsibility
Provide governance-level oversight of contamination-related data, driving continuous improvement and reduction of repeat deviations

What we offer

Excellent salary and benefits package including enhanced pension, healthcare and annual bonus scheme
A chance to make a real difference and lead from the front in a key role on site
Working at the forefront of the biologics industry

Fulltime

Contamination Control Manager

At SRG, we are excited to be partnering with our client, a biologics Contract De...

Location

United Kingdom , Falkirk

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

Degree in Microbiology, Biology, Biochemistry, Chemical Engineering or related discipline (Master's preferred)
Extensive industry experience in sterile or biologics pharmaceutical manufacturing, ideally within a CDMO
Strong expertise in aseptic processing, cleanroom operations and microbiological contamination control
Proven experience leading FMEA and cross-functional risk assessments
Solid understanding of global regulatory expectations
Ability to influence in matrixed environments with strong communication, coaching and facilitation skills

Job Responsibility

Own and evolve the site Contamination Control Strategy in line with EU/UK GMP Annex 1, FDA and ICH expectations
Embed contamination control principles into facility and equipment design, process flows, cleaning and sterilisation strategies, supplier management and training programmes
Partner with Manufacturing to influence aseptic behaviours, shift routines, operator decision-making and capability development
Collaborate with MSAT across equipment design, tech transfer, scale-up, process characterisation and new product introduction
Ensure full integration of the CCS with Quality systems including deviations, investigations, CAPAs, change control and audit readiness
Lead contamination-focused risk assessments (including FMEA) across client processes, shared equipment, utilities, campaign manufacturing and changeovers
Translate risk into practical, executable operational controls and maintain assessments as living tools informed by data and trends
Design and deploy contamination control training tailored to a CDMO environment, reinforcing learning through hands-on coaching and on-the-floor engagement
Champion a strong site-wide contamination control culture where prevention is everyone's responsibility
Provide governance-level oversight of contamination-related data, driving continuous improvement and reduction of repeat deviations

What we offer

Excellent salary and benefits package including enhanced pension, healthcare and annual bonus scheme
A chance to make a real difference and lead from the front in a key role on site
Working at the forefront of the biologics industry

Fulltime

Contamination Control Manager

This is a senior, high-impact role for a contamination control leader who combin...

Location

United Kingdom , Falkirk

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

Degree in Microbiology, Biology, Biochemistry, Chemical Engineering or related discipline (Master's preferred)
Extensive industry experience in sterile or biologics pharmaceutical manufacturing, ideally within a CDMO
Strong expertise in aseptic processing, cleanroom operations and microbiological contamination control
Proven experience leading FMEA and cross-functional risk assessments
Solid understanding of global regulatory expectations
Ability to influence in matrixed environments with strong communication, coaching and facilitation skills

Job Responsibility

Own and evolve the site Contamination Control Strategy in line with EU/UK GMP Annex 1, FDA and ICH expectations
Embed contamination control principles into facility and equipment design, process flows, cleaning and sterilisation strategies, supplier management and training programmes
Partner with Manufacturing to influence aseptic behaviours, shift routines, operator decision-making and capability development
Collaborate with MSAT across equipment design, tech transfer, scale-up, process characterisation and new product introduction
Ensure full integration of the CCS with Quality systems including deviations, investigations, CAPAs, change control and audit readiness
Lead contamination-focused risk assessments (including FMEA) across client processes, shared equipment, utilities, campaign manufacturing and changeovers
Translate risk into practical, executable operational controls and maintain assessments as living tools informed by data and trends
Design and deploy contamination control training tailored to a CDMO environment, reinforcing learning through hands-on coaching and on-the-floor engagement
Champion a strong site-wide contamination control culture where prevention is everyone's responsibility
Provide governance-level oversight of contamination-related data, driving continuous improvement and reduction of repeat deviations

What we offer

Excellent salary and benefits package including enhanced pension, healthcare and annual bonus scheme
A chance to make a real difference and lead from the front in a key role on site
Working at the forefront of the biologics industry

Fulltime

Qc microbiology manager

We are a clinical-stage biotechnology company focused on discovering and develop...

Location

Canada , Vancouver

Salary:

105600.00 - 132000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

Deep, hands-on Microbiology experience in a regulated (GMP) QC environment
experience mentoring or leading team members working within microbiology labs or cleanroom/controlled environments
10+ years of hands-on QC microbiology experience in a GMP setting
Bachelor’s degree in Microbiology or a related life sciences field
clear communication and collaboration
calm, structured decision-making under pressure
strong ownership, accountability, and solutions-focused mindset
organized, detail-oriented, committed to inspection readiness and data integrity
ability to thrive in an environment requiring in-lab leadership, cross-functional coordination, and prioritization of operational needs

Job Responsibility

Serving as the QC Microbiology SME for key strategic decisions related to microbiology, including contamination control, microbiological method strategy, environmental monitoring, utilities monitoring, facility readiness, and risk-based testing approaches
Leading all Microbiology operations, including bioburden, endotoxin, microbial ID, growth promotion, EM sampling, water testing, and trending
Troubleshooting microbiological assays, contamination events, and EM deviations, ensuring timely and compliant resolution
Providing daily in-lab mentorship to the QC team, fostering strong technique, aseptic practices, and microbiological best practices
Ensuring microbiology labs and adjacent QC spaces remain inspection-ready, including GMP housekeeping and equipment readiness
Reviewing micro data packages, protocols, reports, and testing documentation for accuracy and adherence to ALCOA++ principles
Collaborating with Analytical Development, Quality Assurance, Materials, and Manufacturing teammates to ensure smooth operational flow and timely release/testing

What we offer

equity
annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
annual vacation
professional development opportunities
comprehensive health benefits

Fulltime

Quality Assurance Tester

As a QA Micro Associate, CAR-T Europe, you will play a pivotal role in ensuring ...

Location

Belgium , Beerse

Salary:

Not provided

Randstad

Expiration Date

August 18, 2026

Requirements

Bachelor's Degree in Engineering, Science, or an equivalent technical field
Experience in the biological and/or pharmaceutical industry, with relevant micro experience related to manufacturing
Aseptic processing in an ISO 5 cleanroom and biosafety cabinets
Knowledge of cGMP regulations, FDA/EU guidance, and Good Tissue Practices related to cell-based product manufacturing
Detailed knowledge of shop floor manufacturing processes
Strong organizational skills with the ability to work effectively in a team environment and a positive attitude
Excellent written and verbal communication skills in English
Record-keeping abilities in the form of notebooks, technical reports, and protocols
Ability to summarize and present results, and experience with team-based collaborations
Proactive, solution-oriented mindset with the ability to explore new paths and identify possibilities

Job Responsibility

Collaborate with the Process Development team, Quality, and Operations organization to uphold contamination control of the manufacturing facility in alignment with cGMP and Janssen requirements
Conduct aseptic qualifications of manufacturing personnel, including gowning and aseptic processing
Define and impart specific aseptic techniques for crucial process steps through instructor-led trainings and awareness sessions
Drive the Aseptic Oversight program through manufacturing floor surveillance
Support process microbiological investigations actively
Develop relevant quality control documents, Standard Operating Procedures (SOPs), and Work Instructions (WIs)
Maintain, re-evaluate, and communicate key critical inputs for the site's environmental monitoring program
Identify risks and opportunities related to contamination control, collaborating closely with operators, Quality Control (QC), and operations management on improvement initiatives
Perform tasks in compliance with safety policies, quality systems, and cGMP requirements

Quality Associate III

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific field with 8+ years of experience in a regulated pharmaceutical or medical device environment, OR Master's degree in a related field with 5+ years of relevant experience
Experience with microbiological testing and environmental monitoring, particularly in regulated settings
Familiarity with investigation processes (e.g., OOS, OOT, or atypical results) and structured problem-solving approaches
Ability to develop and maintain GMP-compliant documentation (e.g., SOPs, test methods, protocols)
Working knowledge of cGMP and regulatory expectations, including data integrity principles
Experience using laboratory systems (e.g., LIMS or similar tools)
Clear communication skills with the ability to present technical information in an understandable way
Strong organizational skills and the ability to manage multiple responsibilities effectively
Experience in sterile manufacturing or contamination control environments
Exposure to regulatory inspections or audits within a microbiology function

Job Responsibility

Support and guide QC Microbiology activities at RLDD, including environmental monitoring, contamination control, and laboratory operations
Contribute to validation and lifecycle activities for microbiological methods, instruments, and laboratory systems, including qualifications, method transfers, and change assessments
Partner with cross-functional teams to evaluate microbiological risks, support issue resolution, and inform product quality decisions
Lead and support investigations (e.g., deviations, atypical results, EM excursions) using structured, science-based approaches to determine root cause and implement effective corrective actions
Prepare and maintain microbiology documentation such as SOPs, test methods, protocols, and contamination control strategy content, ensuring clarity and compliance with regulatory expectations
Perform laboratory assessments and data reviews to identify improvement opportunities and sustain a state of inspection readiness
Support adoption and continuous improvement of laboratory tools and systems (e.g., LIMS, EM systems, data trending tools) to strengthen efficiency and data integrity
Share knowledge and provide guidance to colleagues
contribute to audits and inspections by preparing documentation and responding to microbiology-related inquiries

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage starting on day one
basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Quality Associate III

Location

United States , Round Lake

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, or a related scientific field with 8+ years of experience in a regulated pharmaceutical or medical device environment, OR Master’s degree in a related field with 5+ years of relevant experience
Experience with microbiological testing and environmental monitoring, particularly in regulated settings
Familiarity with investigation processes (e.g., OOS, OOT, or atypical results) and structured problem-solving approaches
Ability to develop and maintain GMP-compliant documentation (e.g., SOPs, test methods, protocols)
Working knowledge of cGMP and regulatory expectations, including data integrity principles
Experience using laboratory systems (e.g., LIMS or similar tools)
Clear communication skills with the ability to present technical information in an understandable way
Strong organizational skills and the ability to manage multiple responsibilities effectively

Job Responsibility

Support and guide QC Microbiology activities at RLDD, including environmental monitoring, contamination control, and laboratory operations
Contribute to validation and lifecycle activities for microbiological methods, instruments, and laboratory systems, including qualifications, method transfers, and change assessments
Partner with cross-functional teams to evaluate microbiological risks, support issue resolution, and inform product quality decisions
Lead and support investigations (e.g., deviations, atypical results, EM excursions) using structured, science-based approaches to determine root cause and implement effective corrective actions
Prepare and maintain microbiology documentation such as SOPs, test methods, protocols, and contamination control strategy content, ensuring clarity and compliance with regulatory expectations
Perform laboratory assessments and data reviews to identify improvement opportunities and sustain a state of inspection readiness
Support adoption and continuous improvement of laboratory tools and systems (e.g., LIMS, EM systems, data trending tools) to strengthen efficiency and data integrity
Share knowledge and provide guidance to colleagues
contribute to audits and inspections by preparing documentation and responding to microbiology-related inquiries

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Quality Associate III

As a Quality Associate III – QC Microbiology, you will support microbiological q...

Location

United States of America , Round Lake

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific field with 8+ years of experience in a regulated pharmaceutical or medical device environment, OR Master's degree in a related field with 5+ years of relevant experience
Experience with microbiological testing and environmental monitoring, particularly in regulated settings
Familiarity with investigation processes (e.g., OOS, OOT, or atypical results) and structured problem-solving approaches
Ability to develop and maintain GMP-compliant documentation (e.g., SOPs, test methods, protocols)
Working knowledge of cGMP and regulatory expectations, including data integrity principles
Experience using laboratory systems (e.g., LIMS or similar tools)
Clear communication skills with the ability to present technical information in an understandable way
Strong organizational skills and the ability to manage multiple responsibilities effectively
Experience in sterile manufacturing or contamination control environments
Exposure to regulatory inspections or audits within a microbiology function

Job Responsibility

Support and guide QC Microbiology activities at RLDD, including environmental monitoring, contamination control, and laboratory operations
Contribute to validation and lifecycle activities for microbiological methods, instruments, and laboratory systems, including qualifications, method transfers, and change assessments
Partner with cross-functional teams to evaluate microbiological risks, support issue resolution, and inform product quality decisions
Lead and support investigations (e.g., deviations, atypical results, EM excursions) using structured, science-based approaches to determine root cause and implement effective corrective actions
Prepare and maintain microbiology documentation such as SOPs, test methods, protocols, and contamination control strategy content, ensuring clarity and compliance with regulatory expectations
Perform laboratory assessments and data reviews to identify improvement opportunities and sustain a state of inspection readiness
Support adoption and continuous improvement of laboratory tools and systems (e.g., LIMS, EM systems, data trending tools) to strengthen efficiency and data integrity
Share knowledge and provide guidance to colleagues
contribute to audits and inspections by preparing documentation and responding to microbiology-related inquiries

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

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Microbiology and Contamination Control Manager

Job Description

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