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 Senior

Location

Belgium , Wavre

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor's degree in Sciences or equivalent experience
At least 5 years of professional experience in a pharmaceutical manufacturing environment producing sterile drugs or vaccines
Strong understanding of regulatory requirements, including cGMP and relevant international guidelines
Strong sterility assurance and microbiology background
Ability to balance GMP requirements with manufacturing reality
Strong analytical, problem-solving, and root cause analysis skills
Continuous improvement mindset
Excellent interpersonal and communication skills
Proven influencing skills
Training and mentoring capabilities

Job Responsibility

Own the MU’s sterility assurance risk profile, including the transversal strategy to mitigate/remediate risks and continuous improvement of the Sterility Assurance Quality System
Develop, implement, and maintain a comprehensive sterility assurance program/roadmap, including accountability for the MU’s Contamination Control Strategy
Monitor and improve manufacturing processes to identify potential sources of contamination and drive CAPA
Interpret microbiological data and trends, provide holistic recommendations, and drive implementation of process improvements
Perform analyses related to the performance of the area of expertise
Proactively monitor and oversee MU performance related to sterility assurance, including shopfloor Gemba walks
Drive MU compliance to GMP and QMS requirements for sterility assurance
Contribute to sterility assurance knowledge management and coordination across the site/network
Ensure compliance with local and international standards, cGMP, regulatory requirements, and internal QMS policies and procedures, as well as adherence to EHS rules
Act as front-room representative during regulatory and corporate inspections and internal audits

What we offer

Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.

Fulltime

R&D Sterility Assurance - Project Lead

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

Belgium , Braine-l'Alleud

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

B.S. in Engineering with 5–8 years of experience, or M.S. with 2–4 years, or Ph.D. with 1–2 years of relevant industry experience
Strong understanding of engineering principles and cross‑disciplinary collaboration
Knowledge of sterilization modalities (Moist Heat, EtO, Radiation, Aseptic Processing preferred)
Experience in GMP environments and with regulatory expectations for sterile products
Ability to design experiments, analyze data, and draw meaningful conclusions
Analytical, structured problem‑solver with strong decision‑making abilities
Clear, confident communicator able to influence stakeholders and management
Able to work independently in ambiguous environments while balancing quality and business needs
Proven ability to mentor and support junior colleagues
Willingness to travel up to 20%

Job Responsibility

Act as the Sterility Assurance Project Lead / Focal Point for R&D programs
Define and execute sterility assurance strategies, including test method validation plans, rationale statements, and sterilization parameters
Provide interpretation and guidance on GxP and global sterility regulations
Support regulatory submissions related to sterility assurance
Lead sterility assurance activities with a high degree of autonomy across projects of broad scope
Contribute to project planning, budgets, product requirements, and design decisions
Communicate status, risks, and recommendations to cross‑functional teams and leadership
Serve as a technical liaison with manufacturing facilities (domestic and international)
Evaluate and adapt sterilization approaches to optimize quality, safety, and cycle time
Support microbiology test method validations

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

R&D Sterility Assurance - Project Lead

At Baxter, our mission to save and sustain lives is driven by scientific rigor a...

Location

Belgium , Braine-l'Alleud

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

B.S. in Engineering with 5–8 years of experience, or M.S. with 2–4 years, or Ph.D. with 1–2 years of relevant industry experience
Understanding of engineering principles and cross-disciplinary collaboration
Knowledge of sterilization modalities (Moist Heat, EtO, Radiation, Aseptic Processing preferred)
Experience in GMP environments and with regulatory expectations for sterile products
Ability to design experiments, analyze data, and draw meaningful conclusions
Analytical, structured problem-solver with strong decision-making abilities
Clear, confident communicator able to influence stakeholders and management
Able to work independently in ambiguous environments while balancing quality and business needs
Proven ability to mentor and support junior colleagues
Willingness to travel up to 20%

Job Responsibility

Act as the Sterility Assurance Project Lead / Focal Point for R&D programs
Define and execute sterility assurance strategies, including test method validation plans, rationale statements, and sterilization parameters
Provide interpretation and guidance on GxP and global sterility regulations
Support regulatory submissions related to sterility assurance
Lead sterility assurance activities with a high degree of autonomy across projects of broad scope
Contribute to project planning, budgets, product requirements, and design decisions
Communicate status, risks, and recommendations to cross-functional teams and leadership
Serve as a technical liaison with manufacturing facilities (domestic and international)
Evaluate and adapt sterilization approaches to optimize quality, safety, and cycle time
Support microbiology test method validations

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Associate Director, Sterility Assurance

The Associate Director, Sterility Assurance, DP Manufacturing is a senior techni...

Location

United States , Norwood

Salary:

142500.00 - 256500.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

Bachelor's degree in Microbiology, Life Sciences, Pharmacy, or related field (Master's or Ph.D. preferred)
8+ years in sterility assurance, quality control, sterile pharmaceutical manufacturing, or aseptic processing roles
Deep expertise in isolator-based manufacturing, EM programs, contamination control, media fills, and aseptic filling operations
Strong expertise in risk assessment facilitation
Direct involvement in regulatory inspections, root cause investigations, and Quality System document ownership
Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations

Job Responsibility

Lead and maintain the Contamination Control Strategy (CCS) for MTC-E, ensuring alignment with EU Annex 1, FDA aseptic guidance, and internal quality expectations
Ensure practical, risk-based integration of the CCS into isolator operations, cleanroom design, gowning practices, material and personnel flow, environmental controls, and aseptic process execution
Provide sterility assurance expertise for site changes, process improvements, and operational decisions that may impact contamination control
Provide expert sterility assurance guidance on the EM program (strategy, zoning, sampling design, alert/action levels, and trending) and partner with QC to ensure effective monitoring and response aligned with contamination control strategy
Lead or support investigations with potential impact to sterility assurance (e.g., EM excursions, media fill failures, decontamination issues, bioburden or sterility failures), ensuring robust root cause analysis and effective corrective and preventive actions
Present EM performance, contamination control risks, and key trends to site leadership and drive data-based decision-making
Own and author sterility assurance-related Quality System documentation, including change controls, risk assessments, CAPAs, deviations, and other records associated with contamination control, EM, or aseptic practices
Ensure records are scientifically sound, timely, and aligned with site and global quality system requirements
Serve as a key leader in inspection and audit readiness activities, including internal audits, client audits, and regulatory inspections
Act as subject matter expert for CCS, EM, aseptic execution, isolator operations, media fills, and related sterility assurance topics

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
Eligible for an annual discretionary bonus, other incentive compensation, or equity award

Fulltime