Sterility Assurance Lead Job at BioMarin Pharmaceutical (Cork)

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

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
M.S. with 2–4 years
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

Job Responsibility

Act as the Sterility Assurance Project Lead / Focal Point for R&D programs
Define and execute sterility assurance strategies, including test methodvalidation 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

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

Sterility Assurance Specialist

As a Sterility Assurance Specialist, you will be Subject Matter Expert (SME) for...

Location

United States , Marietta

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Bachelor’s degree in microbiology, biology, pharmacy, or related scientific discipline
5+ years pharmaceutical industry experience
GMP/Microbiology/Quality or Aseptic Area role to include direct work with environmental monitoring of aseptic filling operations and sterility assurance systems
Technical expert in sterility assurance process, environmental monitoring and gown monitoring programs
Knowledge of microbiology, contamination control programs to implement and improve cleaning, gowning, aseptic behaviors, material transfer, aseptic simulations and environmental monitoring programs
Experience leading investigations, deviations, or microbiological problem solving
Ability to provide leadership to generate options, resolve problems, prioritize solutions, select optimal solutions and implement decisions

Job Responsibility

Responsible for improving sterility assurance program at Marietta and sharing sterility assurance best practices between Marietta and other GSK aseptic manufacturing sites
Evaluate manufacturing operational practices and strategies to ensure compliance with regulatory requirements. Lead, develop, implement, influence changes to meet requirements and continuously improve sterility assurance processes
Responsible for aseptic process simulations, facility cleaning, material transfer, aseptic behavior, Environmental Monitoring, gowning and contamination control strategy programs. Provide oversight and measure effectiveness of Sterility Assurance programs. Maintain and improve LSOPs (local procedures) for these programs and perform periodic review of local procedures (for example- facility cleaning, aseptic behaviors, material transfer, gowning, EM and aseptic simulations)
Responsible for trending, generating Environmental Monitoring trend reports and ensuring that Environmental Monitoring and gowning programs are in control. Responsible for all rationale documents and risk assessments to support the environmental monitoring and gown monitoring programs
Provide expert advice when changes to classified environments are proposed to evaluate the benefits or disadvantages of the proposed changes and to assist with investigation of excursions. Provide trending data analysis to assist with the evaluation of the impact of excursions. Ensure that the site monitoring strategy for classified areas complies to procedures and external regulatory expectations
Interface directly with domestic and foreign regulatory inspectors regarding microbiological and sterility assurance topics
Participate in the investigation and planned remedial actions for out of compliance EM / Sterility Assurance results in order to support the timely resolution of investigations
Own and execute quality system (CAPA, Change Control, LSOP revisions, gap analysis)
Responsible for training, coaching, and qualification program for aseptic techniques, clean room behaviors, and gowning
Provide technical guidance for all questions and issues related to sterility assurance topics and support 3 shifts of operation, as required

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

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

Quality Lab Associate III - Sterility Assurance

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

Location

United States , Marion

Salary:

80000.00 - 110000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS degree in Biology or Microbiology
Five (5) or more years of professional experience in Laboratory, Quality, Manufacturing, or related field is strongly preferred
Strong understanding of Environmental Monitoring programs, Microbiology concepts and Good Documentation practices is preferred
Detailed knowledge of applicable procedures, specifications, regulations, and standards
Strong analytical and problem-solving skills
Ability to run multiple projects/investigations/priorities
Good communication and leadership skills
Good interpersonal/communication/influencing/negotiation skills
Good project management skills
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings

Job Responsibility

Author and complete Environmental Monitoring Performance Qualifications (EMPQ) related to the manufacturing clean/classified rooms in compliance with local and regulatory requirements
Coordinate sampling activities with EM sampling team and manufacturing department as applicable
Perform Failure Modes and Effects Analysis, as needed
Prepare and present to management the trend reports related to EMPQ and contamination control activities
SME of EMPQ and contamination control aspects providing leadership, technical and quality support to manufacturing and during regulatory inspections or site audits
Understands and assures conformance to regulations
Works with regulators during regulatory inspections
Interacts frequently with functional peer group and managers, as appropriate
Identifies and leads continuous improvement projects with the objective of achieving quality, reliability, and cost improvements
Sustain a clean and safe work area using 6S principles

What we offer

Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
2 Days a Year to Volunteer

Fulltime

Quality Lab Associate III - Sterility Assurance

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

Location

United States , Marion

Salary:

80000.00 - 110000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS degree in Biology or Microbiology
Five (5) or more years of professional experience in Laboratory, Quality, Manufacturing, or related field is strongly preferred
Strong understanding of Environmental Monitoring programs, Microbiology concepts and Good Documentation practices is preferred
Detailed knowledge of applicable procedures, specifications, regulations, and standards
Strong analytical and problem-solving skills
Ability to run multiple projects/investigations/priorities
Good communication and leadership skills
Good interpersonal/communication/influencing/negotiation skills
Good project management skills
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings

Job Responsibility

Author and complete Environmental Monitoring Performance Qualifications (EMPQ) related to the manufacturing clean/classified rooms in compliance with local and regulatory requirements
Coordinate sampling activities with EM sampling team and manufacturing department as applicable
Perform Failure Modes and Effects Analysis, as needed
Prepare and present to management the trend reports related to EMPQ and contamination control activities
SME of EMPQ and contamination control aspects providing leadership, technical and quality support to manufacturing and during regulatory inspections or site audits
Understands and assures conformance to regulations
Works with regulators during regulatory inspections
Interacts frequently with functional peer group and managers, as appropriate
Identifies and leads continuous improvement projects with the objective of achieving quality, reliability, and cost improvements
Sustain a clean and safe work area using 6S principles

What we offer

Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement

Fulltime

Quality Lab Associate III - Sterility Assurance

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

Location

United States , Marion

Salary:

80000.00 - 110000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS degree in Biology or Microbiology
Five (5) or more years of professional experience in Laboratory, Quality, Manufacturing, or related field is strongly preferred
Strong understanding of Environmental Monitoring programs, Microbiology concepts and Good Documentation practices is preferred
Detailed knowledge of applicable procedures, specifications, regulations, and standards
Strong analytical and problem-solving skills
Ability to run multiple projects/investigations/priorities
Good communication and leadership skills
Good interpersonal/communication/influencing/negotiation skills
Good project management skills
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings

Job Responsibility

Author and complete Environmental Monitoring Performance Qualifications (EMPQ) related to the manufacturing clean/classified rooms in compliance with local and regulatory requirements
Coordinate sampling activities with EM sampling team and manufacturing department as applicable
Perform Failure Modes and Effects Analysis, as needed
Prepare and present to management the trend reports related to EMPQ and contamination control activities
SME of EMPQ and contamination control aspects providing leadership, technical and quality support to manufacturing and during regulatory inspections or site audits
Understands and assures conformance to regulations
Works with regulators during regulatory inspections
Interacts frequently with functional peer group and managers, as appropriate
Identifies and leads continuous improvement projects with the objective of achieving quality, reliability, and cost improvements
Sustain a clean and safe work area using 6S principles

What we offer

Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
2 Days a Year to Volunteer

Fulltime

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Sterility Assurance Lead

Job Description

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