The Position
Join a Leader in Pharmaceutical Manufacturing — And Build What’s Next
Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support life-changing medicines around the world. We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global, Jubilant Pharma family.
For the Builders, Innovators, and Doers — This Is Your Place
Purpose of the Job:
The Manager, Environmental Monitoring & Microbiology is responsible for maintaining, and continuously improving the Environmental Monitoring (EM) program to ensure compliance with applicable GMP and regulatory requirements. This role provides expertise, real‑time operational support, and guidance to manufacturing and support areas, ensuring a state of control within classified environments.
The Specialist acts as a key quality partner to Operations by assessing EM risks, supporting investigations, trending data, and recommending scientifically sound corrective actions to prevent contamination events and ensure product quality.
Key Responsibilities
Data Review, Trending, and Reporting
- Review, assess, and interpret EM results against alert and action limits.
- Perform trend analyses of EM data to identify recurring issues, adverse trends, and areas of improvement.
- Prepare and review EM summary reports, dashboards, and periodic trend reports for Quality and operational stakeholders.
Deviations, Investigations, and CAPAs
- Lead or support EM‑related deviations, excursions, and investigations, including root cause analysis and risk assessments.
- Provide subject matter expertise to cross‑functional investigation teams.
- Develop and support implementation of effective and sustainable CAPAs related to environmental control and contamination risks.
- Provide active quality oversight through routine walk‑throughs and presence in manufacturing areas.
Continuous Improvement and Program Enhancement
- Identify opportunities to improve EM program robustness, efficiency, and compliance.
- Support implementation of improvements related to sampling plans, frequencies, limits, and methodologies.
- Participate in contamination control and risk mitigation initiatives.
Documentation and Compliance
- Author, review, and revise SOPs, forms, and work instructions related to environmental monitoring and contamination control.
- Ensure EM activities are inspection‑ready and aligned with regulatory expectations (Health Canada, FDA, EMA).
- Support internal audits and regulatory inspections, including responding to EM‑related observations.
Cross‑Functional Collaboration
- Collaborate closely with Production, Quality Control, Validation, Technical Services, and Engineering.
- Support training of operations personnel on EM principles, contamination control, and GMP expectations.
Person Profile
Desired Certifications:
D.E.C. or BSc in Microbiology or closely related discipline.
Experience Required:
- Minimum five (5) years of experience in Environmental Monitoring, Microbiology, Quality Assurance, or Quality Control within the pharmaceutical or healthcare industry
- Demonstrated experience with:
- GMP environmental monitoring programs
- Aseptic processing and contamination control
- EM investigations and data trending
Skills Required:
- Strong knowledge of GMP requirements related to environmental monitoring and microbiology
- Solid understanding of aseptic processing and contamination control strategies
- Ability to assess risk and criticality of EM excursions and manufacturing events
- Strong investigation and root cause analysis skills
- Proficiency with electronic systems (e.g., MODA, SAP, MS Office)
