CrawlJobs Logo

Sterility Assurance Lead

biomarin.com Logo

BioMarin Pharmaceutical

Location Icon

Location:
Ireland , Cork

Category Icon
Category:
Manufacturing

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

This is a critical leadership role responsible for ensuring that all marketed and investigational drug products manufactured at our site meet the highest sterility and contamination control standards. The successful candidate will act as a key influencer across the site and global operations, shaping contamination control strategies and driving compliance with regulatory expectations. This is an exciting opportunity for a proactive leader to define and implement sterility assurance programs, collaborate cross-functionally, and represent the site as a subject matter expert during audits and inspections.

Job Responsibility:

  • Strategic Leadership: Own and continuously evolve the site’s Contamination Control Strategy, ensuring alignment with global standards and regulatory requirements
  • Regulatory Compliance & Influence: Implement regulatory expectations, maintain compliance with EU GMP Annex 1, 21 CFR, USP, EP, JP, and ICH guidelines, and stay current with emerging global regulations, audit trends and best practices
  • Training & Culture: Design and deliver robust training programs on aseptic processing, behaviors, and contamination control principles to embed a culture of sterility assurance across the site
  • Environmental Monitoring & Utilities: Establish and maintain environmental monitoring and clean utilities programs, ensuring proactive contamination control
  • Technical Expertise: Provide expert input on gowning, cleaning, sanitization & sterilization strategies, microbiological method transfers, and contamination investigations
  • Investigations: Lead and guide the investigation of contamination-related deviations, non-conformances, and sterility failures. Perform root cause analysis, define corrective and preventive actions (CAPAs), and ensure timely closure of quality events
  • Data Analysis & Risk Mitigation: Review microbiological data trends, identify risks, and implement effective mitigation strategies
  • Global Collaboration: Partner with global Technology and Quality functions to ensure site alignment with industry best practices and BioMarin network standards
  • Continuous Improvement: Drive initiatives to enhance microbiological quality, operational efficiency, and inspection readiness
  • Facility Expansion Support: Lead microbiology aspects of facility expansions, including cleanroom qualification and sterilization systems

Requirements:

  • Bachelor’s degree in Microbiology, Biology, Pharmaceutical Sciences, or related discipline (Master’s or PhD preferred)
  • 10–15+ years of progressive experience in microbiology within GMP-regulated pharmaceutical or biotechnology environments
  • Minimum 5 years in leadership roles, with proven ability to influence cross-functional teams and senior stakeholders
  • Significant hands-on experience supporting aseptic sterile fill-finish operations, preferably with isolator qualification and maintenance
  • Strong knowledge of EU GMP Annex 1 and global sterility assurance standards
  • Demonstrated success in leading contamination investigations and regulatory interactions
  • Strategic thinker with strong problem-solving and decision-making abilities
  • Excellent communication and influencing skills across all organizational levels
  • Ability to interpret complex microbiological data and translate into actionable strategies

Additional Information:

Job Posted:
January 06, 2026

Work Type:
On-site work
Icon
BioMarin Pharmaceutical - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Sterility Assurance Lead

Principal Scientist – Sterility Assurance

The Principal Scientist – Sterility Assurance within Technical Services / Manufa...
Location
Location
United States , Durham
Salary
Salary:
65.00 USD / Hour
medasource.com Logo
Medasource
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS or MS in Microbiology, Biology, Biochemistry, Chemical/Biochemical Engineering, or related scientific discipline
  • Experience with parenteral drug product manufacturing in a cGMP environment
  • Experience supporting cGMP operations in areas such as environmental monitoring, sterility assurance validation, contamination control, technical services/MSAT, microbiology laboratory, or quality assurance
Job Responsibility
Job Responsibility
  • Provide technical guidance and oversight of aseptic processing activities to operational Process Teams
  • Support or lead investigations related to sterility assurance, including root cause analysis and remediation
  • Perform scientific and risk-based evaluations of aseptic processes, environmental monitoring, disinfectant efficacy studies, sanitization programs, and contamination control strategies
  • Support start-up and tech transfer activities related to sterile manufacturing operations
  • Analyze microbial, manufacturing, and environmental monitoring data using statistical principles to identify trends, process disruptions, and improvement opportunities
  • Conduct periodic review of EM program performance and recommend enhancements to ensure a state of control
  • Use risk management tools to evaluate proposed processes and associated controls for microbial, particulate, and endotoxin risk
  • Create, execute, review, and/or approve technical documents, including protocols, reports, procedures, and change controls
  • Support internal and external audits by providing subject-matter expertise in sterile manufacturing, environmental monitoring, and contamination control
  • Participate in continuous improvement projects aimed at strengthening quality systems and sterility assurance programs
What we offer
What we offer
  • Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs
  • We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays
  • We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc
Read More
Arrow Right

Quality Assurance Officer

We have a fantastic opportunity for a Quality Assurance Officer to join our Radi...
Location
Location
United Kingdom , Preston
Salary
Salary:
Not provided
alliancemedical.co.uk Logo
Alliance Medical Ltd
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience in Quality Assurance within a GMP environment
  • Good organisation skills
  • Proactive with a can-do attitude
  • Detail-focused and time-oriented
  • Excellent grasp of problem solving and report writing skills
  • Good at both working on tasks in a team and independently
  • Experience in Good Manufacturing Practice (GMP) is essential
  • Degree or higher in relevant scientific area (pharmacy, chemistry, or Biology) or equivalent experience in a pharmaceutical setting
  • A strong background in Quality Assurance, preferably with experience in Quality Assurance to produce Sterile injectable products and/or radiopharmaceuticals but is not essential
  • Ideally has a practical experience in activities of quantitative and qualitative analyses of active substances and of the necessary testing and checking to ensure the quality of medicinal products or associated relevant experience
Job Responsibility
Job Responsibility
  • Supporting the QA Manager in overseeing GMP compliance and the effectiveness of the Quality Management Systems supporting the manufacturing, testing and release of the product
  • Fulltime
Read More
Arrow Right

Sterility Assurance Scientist

This technical role is responsible for developing and implementing the site’s st...
Location
Location
United States , Concord
Salary
Salary:
35.00 USD / Hour
medasource.com Logo
Medasource
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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.
Read More
Arrow Right

Sterility Assurance Lead

Senior QA Subject Matter Expert role for a full-time contract of approximately 6...
Location
Location
United Kingdom , Swindon
Salary
Salary:
50.00 - 75.00 GBP / Hour
https://www.randstad.com Logo
Randstad
Expiration Date
February 17, 2026
Flip Icon
Requirements
Requirements
  • Master Degree in Microbiology
  • At least 5 proven years experience in microbiology in pharmaceutical industry
  • Practical knowledge in GMPs and Regulatory Compliance, especially for sterility assurance (EU GMP annex 1)
  • Extensive background on sterility assurance, process and cleaning validation concepts and contamination control strategy
  • Strong interpersonal and communications skills
  • Ability to make scientific decisions
  • Able to coach and mentor more junior employees
  • Participates and/or leads meetings
  • On-call services, remote, based on department organization
  • Fluency in English
Job Responsibility
Job Responsibility
  • Own and drive the Contamination Control Strategy and Sterility Assurance strategy for the site
  • Assure the surveillance plan of operational activities
  • Collaborate on the floor on the management of quality events with an impact on sterility
  • Owns and maintains the site microbiology risk assessment and Sterilization-in-place concept
  • Responsible for writing and/or review of SOPs related to sterility assurance
  • Support the EM review/evaluation including the relevant action plan
  • Fulltime
Read More
Arrow Right
New

Aseptic Officer

In this vital role you will provide technical leadership and oversight of asepti...
Location
Location
United States , Thousand Oaks
Salary
Salary:
114990.00 - 139433.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
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
Read More
Arrow Right

Quality Inspector

The Quality Inspector is responsible for performing and documenting inspections ...
Location
Location
United States , Chanhassen
Salary
Salary:
Not provided
medsourcelabs.com Logo
MedSource Labs
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School Diploma or equivalent
  • technical training or quality certification preferred
  • 1–3 years of experience in product inspection, preferably in a regulated medical device or manufacturing environment, preferred
  • Familiarity with ISO 13485:2016 and 21 CFR 820 quality system requirements
  • Proficiency in Microsoft Excel, Outlook, and PowerPoint
  • experience with electronic quality management systems preferred
  • Strong written and verbal communication skills, with excellent attention to detail
  • Ability to lift and transfer up to 25 lbs.
Job Responsibility
Job Responsibility
  • Perform visual inspections of incoming product shipments in accordance with approved inspection plans and work instructions
  • Review supplier documentation (e.g., Certificates of Conformance, Certificates of Analysis, test reports, sterilization documents, and finished goods inspection records) for completeness and compliance prior to product acceptance
  • Accurately document inspection results in the Electronic Quality Management System (eQMS) and maintain traceability to lot numbers, purchase orders, and inspection records
  • General document and record control responsibilities related to product inspections
  • Identify, segregate, and document nonconforming product per the Control of Nonconforming Product procedure
  • Maintain and update inspection forms, inspection criteria, and the eQMS inspection module as required
  • Perform on-site product testing as needed
  • Notify the Quality Assurance Lead of issues that could impact product compliance, processes, or customer satisfaction
  • Assist in analysis of returned products and contribute to root cause investigations, Corrective and Preventive Actions (CAPA), and process improvements
  • Support internal audits and regulatory inspections by providing inspection records and evidence of compliance
  • Fulltime
Read More
Arrow Right
New

Pharmacy Director

Are you a passionate Pharmacy Director eager to excel in a fulfilling career clo...
Location
Location
United States , Dothan
Salary
Salary:
Not provided
encompasshealth.com Logo
Encompass Health
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Licensed in good standing by the State Pharmacy Board for the state where the hospital is located
  • Successful completion of a degree from an accredited pharmacy program or one recognized as substantially equivalent to a U.S. accredited program by an appropriate certifying agency
  • A minimum of 2 years of supervisory experience
  • May be required to work weekdays and/or weekends, evenings and or night shifts
  • May be required to work on religious and/or legal holidays on scheduled days/shifts
Job Responsibility
Job Responsibility
  • Convey the mission of the hospital and organization to pharmacy staff, holding them accountable for performance, while motivating them to enhance and develop their capabilities
  • Oversee the pharmacy department's operations, including scheduling, continuous assessment, and the implementation of process improvements to optimize department performance
  • Provide direct patient and pharmaceutical care
  • Demonstrate and maintain competence in clinical health system pharmacy practices, including antimicrobial stewardship, non-sterile and sterile drug preparation, controlled substances, hospital pharmacy accreditation, anticoagulation drug therapy management, and medication safety
  • Educate staff on pharmaceutical care and medication management, ensuring the pharmacy consistently complies with local, state, and national regulations
  • Stay current with new medications, indications, and evidence-based medicine
  • Collaborate with the Controller to prepare and manage departmental budgets for staffing, drugs, and supplies
  • Actively serve and lead various hospital committees, including Quality Assurance, Formulary, Pharmacy and Therapeutics, MEC, and Safety, as needed
What we offer
What we offer
  • Affordable medical, dental, and vision plans for both full-time and part-time employees and their families
  • Generous paid time off that accrues over time
  • Opportunities for tuition reimbursement and continuing education
  • Company-matching 401(k) and employee stock purchase plans
  • Flexible spending and health savings accounts
  • A vibrant community of individuals passionate about the work they do
  • Fulltime
Read More
Arrow Right
New

Pharmacy Director

Acknowledge and Appreciate for Your Expertise as Pharmacy Director. Are you a pa...
Location
Location
United States , Littleton
Salary
Salary:
Not provided
encompasshealth.com Logo
Encompass Health
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Licensed in good standing by the State Pharmacy Board for the state where the hospital is located
  • Successful completion of a degree from an accredited pharmacy program or one recognized as substantially equivalent to a U.S. accredited program by an appropriate certifying agency
  • A minimum of 2 years of supervisory experience
  • May be required to work weekdays and/or weekends, evenings and or night shifts
  • May be required to work on religious and/or legal holidays on scheduled days/shifts
Job Responsibility
Job Responsibility
  • Convey the mission of the hospital and organization to pharmacy staff, holding them accountable for performance, while motivating them to enhance and develop their capabilities
  • Oversee the pharmacy department's operations, including scheduling, continuous assessment, and the implementation of process improvements to optimize department performance
  • Provide direct patient and pharmaceutical care
  • Demonstrate and maintain competence in clinical health system pharmacy practices, including antimicrobial stewardship, non-sterile and sterile drug preparation, controlled substances, hospital pharmacy accreditation, anticoagulation drug therapy management, and medication safety
  • Educate staff on pharmaceutical care and medication management, ensuring the pharmacy consistently complies with local, state, and national regulations
  • Stay current with new medications, indications, and evidence-based medicine
  • Collaborate with the Controller to prepare and manage departmental budgets for staffing, drugs, and supplies
  • Actively serve and lead various hospital committees, including Quality Assurance, Formulary, Pharmacy and Therapeutics, MEC, and Safety, as needed
What we offer
What we offer
  • Affordable medical, dental, and vision plans for both full-time and part-time employees and their families
  • Generous paid time off that accrues over time
  • Opportunities for tuition reimbursement and continuing education
  • Company-matching 401(k) and employee stock purchase plans
  • Flexible spending and health savings accounts
  • A vibrant community of individuals passionate about the work they do
  • Fulltime
Read More
Arrow Right
Jobs by Category
Art and Entertainment Jobs Banking Jobs Call Center Jobs Construction Jobs Consulting Jobs Customer Service Jobs Education Jobs Energy Jobs Finance Jobs Gastronomy Jobs Health and Beauty Jobs Hospitality and Tourism Jobs Human Resources Jobs Insurance Jobs IT - Administration Jobs IT - Software Development Jobs Legal Jobs Logistics Jobs Manufacturing Jobs Marketing, Digital Marketing, SEO, SEM Jobs Media Jobs Nursing Jobs Office Administration Jobs Pharmacy Jobs Physical Work Jobs Public Relations Jobs Public Sector Jobs Purchasing Jobs Quality Control Jobs Real Estate Jobs Research and Development Jobs Sales Jobs
Job Positions Jobs by Country
United States Jobs United Kingdom Jobs India Jobs Canada Jobs Australia Jobs Germany Jobs Ireland Jobs Poland Jobs
Company
Blog About Us Contact
Follow Us
Facebook
X (Twitter)
LinkedIn
Instagram
© 2026 CrawlJobs Ltd. All Rights Reserved
Terms & Conditions Privacy Policy