Sterility Assurance Microbiology Engineer Job at Baxter (Thetford)

Senior QA Executive 1

You will play a key role in ensuring quality and compliance in a modern manufact...

Location

Singapore , Tuas

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Bachelor’s degree in science, microbiology, biotechnology, pharmacy, engineering, or a related discipline
At least 6 years of experience in quality assurance within the pharmaceutical or biologics industry
Strong knowledge of GMP and regulatory requirements relevant to manufacturing and quality
Practical experience with deviations and CAPA processes
Experience with validation, qualification and change control practices
Good written and verbal communication skills in English

Job Responsibility

Provide QA oversight - Sterility Assurance for site manufacturing processes and products manufactured by the site
Provide QA oversight – Quality control laboratory for Microbiology and Endotoxin tests
Develop, implement, and monitor sterility assurance programme on site
Lead sterility assurance activities: sterile process oversight, container closure integrity (CCI) strategies, aseptic process simulation (media fills), and bioburden or sterility-related investigations
Develop, review and approve microbiology and sterility-related SOPs, specifications, and test methods
ensure documentation is current and GxP-compliant
Provide technical direction for microbiology method development, transfer, validation, troubleshooting, root cause analysis, and corrective/preventive actions (CAPA)
Manage deviations, OOS/OOT events and non-conformances related to microbiology and sterility
lead investigations and ensure timely regulatory-compliant reporting
Establish and maintain environmental monitoring programmes

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Sterility Assurance Scientist

This technical role is responsible for developing and implementing the site’s st...

Location

United States , Concord

Salary:

35.00 USD / Hour

Medasource

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
Demonstrated understanding and experience with scientific principles for manufacturing parenteral drug products under cGMP conditions, including operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance
2+ years (Senior) or 5+ years (Principal) pharmaceutical manufacturing experience in microbiology, sterility assurance, TSMS, or related departments
Technical expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, cleaning/sanitization strategies, and disinfectant efficacy
Knowledge of microbiological media, enumeration techniques, and microorganism isolation and identification (Principal level)
Strong interpersonal, organizational, oral, and written communication skills for cross-functional teamwork and technical documentation
Experience with data analysis, trending, and root cause investigations related to sterility assurance programs
Ability to wear appropriate PPE and gown into cleanroom attire as required for manufacturing or laboratory environments
Flexibility to support varying production schedules, including occasional extended or off-hour work and travel for training and implementation
Ability to perform tasks requiring repetitive motion, standing or walking for long periods

Job Responsibility

Develop and implement sterility assurance programs and contamination control strategies for the site
Provide technical guidance and oversight for environmental monitoring, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization activities, including disinfectant efficacy
Lead or support technical activities related to airflow pattern testing, environmental monitoring performance qualifications (EM PQ), aseptic processing techniques, and facility monitoring
Author, execute, review, and approve technical documents, protocols, and change controls related to sterility assurance programs
Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvement
Apply sterility assurance risk management to evaluate manufacturing processes and associated controls for potential microbial, endotoxin, and particulate contamination
Lead or support root cause investigations and corrective actions for sterility assurance issues
Participate in and provide technical support during internal and external audits
Mentor team members and collaborate with cross-functional teams to achieve business and quality objectives
Support the development and maintenance of cleanroom gowning and aseptic technique strategies/programs

What we offer

Competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs
401k plan that includes a company match and is fully vested after you become eligible
Paid time off, sick time, and paid company holidays
Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

New

Sterility Assurance Microbiology Engineer

Baxter Thetford have a fantastic opportunity for Microbiology Engineer to join t...

Location

United Kingdom , Thetford

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Degree in Microbiology, Biomedical Science, Bioscience OR Pharmaceutical Science
Working in an environment where accuracy, numeracy, clear documentation and attention to detail are key requirements

Job Responsibility

Operate as part of the Sterility Assurance group
Quality System & Regulatory Compliance: Maintain alignment with EU GMP & Guidelines
Sample preparation and processing of biological indicators
Carry out environmental monitoring for classified areas
Support with atypical sterilisation investigations
Support with heat studies
Investigation and communication of “Out of specification” results and the identification and implementation of CAPA
Support for projects relating to environmental monitoring
Compliance with EHS/GMP/GDP/Company and corporate policies and external regulatory requirements
Other Activities as deemed to be required to support the Thetford manufacturing operation

What we offer

25 days annual leave + bank holidays
Employee discount scheme
Blue light card
Fantastic internal progression opportunities
Subsided canteen
Westfield healthcare
Up to 8% pension contribution
Employee assistance program
Support for Parents
Continuing Education/ Professional Development

Fulltime

Aseptic Officer

In this vital role you will provide technical leadership and oversight of asepti...

Location

United States , Thousand Oaks

Salary:

114990.00 - 139433.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Master’s degree and 2 years of operations or quality experience
Bachelor’s degree and 4 years of operations or quality experience
Associate’s degree and 8 years of operations or quality experience
High school diploma / GED and 10 years of operations or quality experience
10+ years of biopharmaceutical or medical technology experience with increasing responsibility
Bachelor’s or Master’s degree in Microbiology, Life Sciences, or a related field
Demonstrated expertise in aseptic processing, isolator operations, and media fill program management
Experience supporting regulatory inspections and contamination control initiatives in a sterile manufacturing environment
In-depth understanding of cGMPs, aseptic technique, and sterility assurance principles

Job Responsibility

Lead the Aseptic Technique Program for the suite, including routine observation of critical operations, data trending, and implementation of corrective and preventive actions (CAPAs)
Provide coaching and mentoring to operations personnel to strengthen aseptic practices and contamination control awareness
Author, review, and maintain aseptic-related SOPs, reports, and training materials to ensure alignment with current regulatory expectations and site standards
Partner closely with Quality Assurance, Validation, and other site Aseptic Officers to ensure consistent execution and knowledge sharing across functions
Represent Manufacturing during internal and external inspections, demonstrating robust understanding and control of aseptic practices
Lead the Media Fills supporting the site’s one of two isolator-based filling lines
Author and implement media fill protocols, complete final reports, and perform data trending and risk analysis
Partner with Manufacturing, Quality, and Engineering to ensure execution aligns with aseptic process design, batch records, and contamination control strategy
Evaluate results, find opportunities for process or operator improvement, and ensure timely closure of associated investigations and CAPAs
Support contamination and cross contamination control initiatives and provide aseptic expertise in investigations, deviations, and change controls

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Senior Manager Validation

Reporting to the Associate Director of Validation, the Senior Manager of Validat...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Typically 8+ years of experience in management position
Typically 4+ years' experience supervising validation / technical staff
Graduate degree in Science (Microbiology, Cell Biology, Biochemistry an advantage) or Engineering
Significant experience working in a GMP environment within the pharmaceutical/biotechnology industry in the areas of process, plant, equipment, cleaning, analytical methods and computer systems validation
Detailed knowledge of the regulatory requirements across a range of geographies but particularly the US, EU, Canada, Australia and Japan
Substantial experience within the biotechnology sector, with prior experience in the areas of sterile liquid filling, packaging and labelling an advantage

Job Responsibility

Lead in the development of Validation’s vision, mission, strategies, goals and objectives
Maintain, implement and continuously develop a Validation strategy
Responsible for providing Validation expertise in area of equipment sterility, aseptic processing simulation (or media fill) and temperature mapping
Manage the qualification/validation of production equipment, utilities and systems directly associated with sterility of equipment and processes
Provide support for Tech Transfers (NPIs and LCMs) and regulatory submissions
Oversee the preparation, execution, documentation and reporting of validation studies
Responsible for the development, revision, review, and approval of Standard Operating Procedures
Strong people and project management skills with proven ability to define and execute the validation elements of a projects from design to routine facility operation
Capable of creating a team environment among existing site groups and creating a unified culture within the validation organization
Assure the appropriate level of training is undertaken for all levels of the validation organization

Fulltime

New

Software Engineer II

Microsoft Teams provides a world class solution for collaboration in corporate, ...

Location

Canada , Vancouver

Salary:

85000.00 - 166800.00 CAD / Year

Microsoft Corporation

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Computer Science or related technical field AND 2+ years technical engineering experience with coding in languages including, but not limited to, C, C++, C#, Java, JavaScript, or Python
OR equivalent experience
Ability to meet Microsoft, customer and/or government security screening requirements
Microsoft Cloud Background Check
Master's Degree in Computer Science or related technical field AND 2+ years technical engineering experience
OR Bachelor's Degree in Computer Science or related technical field AND 4+ years technical engineering experience
OR equivalent experience
Proficient in Swift, Objective-C and familiarity with native iOS architecture, frameworks, and Xcode
Experience with cross-organizational projects requiring collaboration and communication skills
Experience building end-user experiences

Job Responsibility

Work closely with PM and designers to architect, design, implement and release features in alignment with product and area charters and priorities
Work closely with infra team and partner team for E2E architecture and API design
Improve Product/Feature quality and reliability
Contribute to a culture of technical excellence and continuous improvement

Fulltime

New

Data Scientist, Product

Meta Platforms, Inc. (Meta), formerly known as Facebook Inc., builds technologie...

Location

United States , Menlo Park

Salary:

214228.00 - 235400.00 USD / Year

New

Apprentice Light Vehicle Technician

We are looking to recruit an Apprentice Light Vehicle Technician to join our bus...

Location

United Kingdom , Glasgow

Salary:

8.00 GBP / Hour

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

GCSE or equivalent in Maths/English and one other (Grade 4/C or above)
passion and interest in the motor industry
team player
meticulous attention to detail
dedicated and motivated mentality

Job Responsibility

Carrying out maintenance and repair work
visual inspections to customer vehicles
completion of relevant documentation
working with System Technicians on more complex and extensive diagnostic and repair tasks

What we offer

25 days holiday rising with length of service - plus bank holidays
Access to online rewards platform giving cash back and discounts for multiple retailers
Preferential Service Rates
Colleague Purchase Scheme
Share Incentive Scheme
Pension
Enhanced Maternity & Paternity
on-going training opportunities
Manufacturer accredited qualification up to a Level 3 in Automotive Repair

Fulltime

Sterility Assurance Microbiology Engineer

Baxter

Location:
United Kingdom , Thetford

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 05, 2026

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Location:United Kingdom , Thetford

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Job Description:

Job Responsibility:

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