Contamination Control Manager

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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.

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Contamination Control Manager

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.

• 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.

• 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.

• 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.

• 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.

• Champion a strong site-wide contamination control culture and awareness where:
  • Contamination prevention is everyone’s responsibility
  • Teams proactively identify, communicate and escalation 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…