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- Tasks: Lead and enhance contamination control strategies in a dynamic CDMO environment.
- Company: Join Piramal Pharma Solutions, a global leader in drug development and manufacturing.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on continuous improvement and innovation.
- Why this job: Make a real impact on health by ensuring product safety and quality.
- Qualifications: Bachelor's degree in a relevant field and 7-10 years of experience in biologics.
The predicted salary is between 60000 - 80000 £ per year.
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.
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.
- 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
- 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
- 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
- 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
- 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
- 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
- Support preparation and readiness efforts 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.
- 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
- 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
- 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 Manager employer: Piramal Pharma Limited
Contact Detail:
Piramal Pharma Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Contamination Control Manager
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their contamination control strategies and be ready to discuss how your experience aligns with their needs. Show them you’re not just another candidate!
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online resources to refine your answers. Focus on articulating your experience in contamination control and how you can contribute to their team.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in joining our team at Piramal Pharma Solutions.
We think you need these skills to ace Contamination Control Manager
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in contamination control and biologics. We want to see how your skills align with the role, so don’t hold back on showcasing your relevant achievements!
Showcase Your Expertise: When writing your application, emphasise your knowledge of global regulatory expectations and your hands-on experience in aseptic processing. We’re looking for someone who can hit the ground running, so let us know what you bring to the table!
Be Clear and Concise: Keep your application straightforward and to the point. Use bullet points where possible to make it easy for us to read through your qualifications and experiences. We appreciate clarity, so don’t be afraid to get straight to the good stuff!
Apply Through Our Website: We encourage you to submit your application directly through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy – just a few clicks and you’re done!
How to prepare for a job interview at Piramal Pharma Limited
✨Know Your Contamination Control Strategies
Before the interview, make sure you’re well-versed in contamination control strategies, especially those relevant to biologics and CDMO environments. Familiarise yourself with global regulatory expectations like UK/EU GMP Annex 1 and FDA guidelines, as these will likely come up during your discussion.
✨Showcase Your Cross-Functional Collaboration Skills
This role requires working closely with various teams like Manufacturing and Quality. Prepare examples of how you've successfully collaborated across departments in the past, particularly in relation to contamination control or risk management. Highlight your ability to influence without authority in a matrixed environment.
✨Prepare for Risk Assessment Discussions
Be ready to discuss your experience with FMEA and other risk assessment methodologies. Think of specific instances where you identified contamination risks and implemented practical controls. This will demonstrate your hands-on experience and problem-solving skills.
✨Emphasise Training and Culture Building
Training is a key part of this role, so be prepared to talk about how you've designed or delivered training programmes in the past. Share your thoughts on fostering a strong contamination control culture and how you’ve engaged teams in proactive risk identification and communication.