Contamination Control Specialist
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
- Responsible for the leadership, management, implementation and sustainability of the site’s Contamination Control and Cleaning Programs.
- Works closely with stakeholders in manufacturing, quality assurance, technical services, facilities and EHS to drive alignment of cleaning program and contamination control goals and improvement initiatives.
- Supports new projects/new molecules to ensure appropriate contamination controls and cleaning regimens are in place as it relates to manufacturing processes, equipment design, and cleaning test method development, verification and validation.
- Ensures Contamination Control and Cleaning Programs comply with and adhere to cGMPs and industry standards/expectations.
Main tasks and responsibilities will include:
- Assure the implementation and maintenance of a cleaning verification and validation programs that conforms to cGMPs and industry standards/expectations
- Monitor results of cleaning verification/validation, and environmental monitoring reports generated from equipment and facilities. Critically analyze data and initiate actions to drive improvements to ensure program robustness.
- Establish standards for cleaning methods, processes and cleaning verification/validation programs. Contribute to and review/approve verification and validation protocols and reports for equipment and facility cleaning.
- Establish and maintain clean and dirty hold times that are based on cleaning and environmental monitoring results.
- Establish and maintain a cleaning validation program for the commercial products manufacturing facility
- Ensure cleaning agents are properly selected, qualified, and controlled.
- Perform and maintain cleaning and contamination control risk assessments that assure the quality of products and safety of employees.
- Work with stakeholders in formulation development, manufacturing, quality assurance, analytical, technical services, facilities and EHS on establishing and monitoring alert and action limits related to environmental monitoring and associated cleaning programs,
- Provide coaching and mentoring on contamination control and cleaning requirements.
- Act as the cleaning and contamination control SME. Support customer audits and regulatory inspections to address any questions about contamination control and cleaning programs and ensure that any audit findings related to these programs are addressed in a thorough and timely manner.
- Lead investigations related to contamination control, environmental monitoring, and equipment/facility cleaning. Ensure investigations are thorough and timely and reports are accurate, clear and concise.
- Support new equipment and new process design to ensure cleaning effectiveness.
- Independently plan, manage and execute assignments, contribute to project planning meetings, communicate any changes in plans or timelines
- Ability to communicate clearly and write in a technically proficient manner within a regulatory environment including protocols, reports, and SOPs
- Assure that all work is performed in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Assures group complies with all company and site policies and procedures
- Remain current in profession and industry trends including pharmaceutical cGMPs
- Ability to work independently and as part of a team with internal and external customer and/or vendor teams
- Analyze and determine best solutions based on needs and company goals, provide recommendations based on best industry practices
The job may involve the following:
- Very high concentration of work
- Strict and tight deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working in a hazardous environment with high requirement to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands
- Bachelor's degree or higher in Microbiology, Science or Engineering.
- 7+ years of relevant experience in cleaning verification / validation and/or contamination control in biotechnology or pharmaceutical industry
- Experience with high potency APIs (HPAPI) strongly preferred
- Thorough knowledge of cGMP regulations with special attention to cleaning verification / validation, environmental monitoring and contamination control
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.