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Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Microbiology & Contamination Control Manager
Job Description
The Contamination Control Manager is responsible for leading, developing, and continuously enhancing the company’s established integrated contamination control strategy within a biologics Contract Development and Manufacturing Organization (CDMO) environment. This role works closely with Manufacturing, MSAT, and Quality to drive proactive identification, reduction and elimination of contamination risks across multiple facilities, client products & processes. The role is responsible for ensuring that the CCS is dynamic, effective and evolves in alignment with business needs, regulatory expectations and future-state technologies.
Key Responsibilities
Contamination Control Strategy (CCS)
- Lead development and maintenance of the site Contamination Control Strategy (CCS) aligned with global regulatory expectations (including UK/EU GMP Annex 1, FDA & ICH guidelines).
- Ensure contamination control principles are embedded across:
- Supplier and Service Provider Selection and Management
- Facility and Equipment Design
- Process Flows (open and closed systems)
- Facility and Equipment cleaning, sanitisation, sterilisation, pyrogen reduction, and material/personnel/waste flows
- Learning & Development curricula
- Adapt contamination control strategies to effectively support diverse client processes, modalities and manufacturing technologies.
CDMO Cross-Functional Partnership
- Partner with Manufacturing to integrate contamination control into:
- Shift routines and pre-job briefs
- Aseptic behaviours and operator practices
- Day-to-day decision making on the floor
- Training and capability building
- Collaborate with MSAT to embed contamination prevention during:
- Equipment detailed design and specification
- Tech transfer and scale-up activities
- Process characterization and control strategy development
- Introduction of new client processes and products
- Data utilisation and CCS integration
- Commissioning, qualification, and readiness activities
- Work with Quality to ensure the CCS is fully integrated with deviations, investigations, CAPAs, change control, and audit readiness activities.
Risk Management & FMEA
- Lead and facilitate contamination-focused risk assessments (using FMEA and other appropriate methodologies) across:
- Client-specific processes and modalities
- Shared equipment, utilities and multiproduct/dedicated facilities
- Changeovers, campaign manufacturing, and process transfers
- Ensure risks are translated into practical, executable controls.
- Maintain all contamination risk assessments as living tools, updated based on operational experience, trends, deviations, qualification data and client feedback.
Training & Workforce Readiness
- Design and deploy contamination control training programs tailored to a CDMO environment, addressing:
- Variability between client processes and modalities
- Operator experience levels
- Critical aseptic behaviours, interventions, and human factor risks
- Reinforce training through on-the-floor, hands on practical methods, coaching, simulations, and day to day engagement.
- Partner with Manufacturing leadership to build discipline, muscle memory, and consistency across shifts and establish periodic requalification and competency verification.
Culture & Behavioural Excellence
- Champion a strong site-wide contamination control culture and awareness where:
- Contamination prevention is everyone’s responsibility
- Teams proactively identify, communicate and escalate risks
- Near-misses and learning opportunities are shared and acted upon
- Act as a visible presence in operational areas, reinforcing accountability, expectations and coaching behaviours in real time.
- Support leadership in driving consistent standards across products and clients.
Data Trending & Continuous Improvement
- Provide governance level oversight of contamination related data. Ensure the site CCS is informed by robust, accurate and timely trends, including:
- Environmental and personnel monitoring
- Microbiological excursions and alert/actions
- Deviation themes, near misses and human-factor patterns
- Utility- related contamination risks
- Cleaning effectiveness and disinfectant performance trends
- Use data to drive preventive actions and continuous improvement.
- Support initiatives aimed at continuous improvement, reducing repeat deviations, improving right-first-time performance, and enhancing client confidence.
Client & Inspection Support
- Support preparation and readiness efforts and for audits and regulatory inspections as the contamination control SME.
- Clearly articulate the site CCS, risk-based rationale, and operational controls to clients and inspectors.
- Partner with site and client teams to address contamination risks while maintaining compliance and operational flexibility.
Required Qualifications
- Bachelor’s degree in microbiology, biology, biochemistry, chemical engineering, or related discipline (Master’s Degree is preferred).
- 7–10+ years’ experience in biologics or sterile pharmaceutical manufacturing, preferably in a CDMO environment.
- Strong expertise in:
- Aseptic processing and cleanroom operations
- Microbiological contamination control
- Multi-product, multi-client manufacturing models
- Demonstrated experience leading FMEA and cross-functional risk assessments.
- Solid understanding of global regulatory expectations related to contamination control.
Key Competencies
- Ability to influence without authority in a matrixed CDMO environment
- Strong facilitation, coaching, project management and communication skills
- Practical, operations-focused problem solving
- Comfort working between client expectations and internal execution
- High level of integrity and ownership
Preferred Experience
- Direct experience supporting tech transfer into commercial manufacturing
- Hands-on involvement with EU GMP Annex 1 implementation
- Experience preparing sites for regulatory inspections and client audits
- Background in facilities with shared equipment and campaign manufacturing
Contamination Control, Sanitization
