Scientist Cleaning and Contamination Control – Process Translation & Execution Clinical Trial API

Key Responsibilities

• Design and develop the Foundry’s cleaning strategy and drive implementation of the site cleaning program.
• Define equipment sets, characterize product groups, select appropriate cleaning agents and cycles, and conduct recovery and cleanability studies to ensure effective and compliant cleaning processes.
• Establish cleaning acceptance criteria / carryover limits and collaborate with the analytical laboratory to ensure that analytical methods are appropriate to mitigate risk and maintain patient safety.
• Maintain a comprehensive understanding of the cleaning verification and changeover processes and apply this knowledge to ensure compliance and effectiveness.
• Develop and maintain site Standard Operating Procedures (SOPs), policies, and standardized cleaning documentation to ensure regulatory compliance, operational consistency, and adherence to industry best practices.
• Support the development and ongoing execution of a cleaning and inspection training program for the Foundry.
• Provide support to other Foundry operational readiness workstreams, such as Operations, Quality, Analytical Labs, HSE, and Engineering.
• Develop and execute cleaning plans using a risk-based approach for manufacturing equipment and supporting systems.
• Support Operations Process Teams in developing plans and schedules for cleaning activities and equipment changeovers.
• Facilitate remediation activities as required to ensure cleaning processes remain compliant and on schedule, enabling timely return of equipment to service without disruption to production timelines.
• Ensure that all cleaning processes and instructions are performed in accordance with HSE requirements.
• Participate in safety audits, Process Hazard Reviews, walkthroughs, and floor time programs related to the equipment cleaning process.
• Collaborate with Site Quality to ensure compliance with internal and external cGMP/cGLP equipment cleaning requirements.
• Update, review, and/or approve cleaning related SOPs, instructions, and other related documentation, ensuring adherence to data integrity principles.
• Review and approve all change controls for cleaning program improvements.
• Collaborate with cross-functional teams to conduct product impact assessments and apply formal problem-solving methodologies, including root cause analysis, for resolving cleaning-related deviations.
• Lead continuous improvement of the site cleaning program, improving efficiency of cleaning processes and identify program improvements.

Basic Requirements

• BS or MS in Chemistry, Biology, Biochemistry, Chemical/Biological Engineering, or related disciplines
• BS with 5 years or MS with 3 years experience in qualification/validation of GMP facilities and process equipment in a pharmaceutical/ biopharmaceutical facility. Knowledge of equipment cleaning lifecycle approach and regulatory requirements.

Additional Preferences

• Capable of collaborating effectively within a team, making autonomous decisions, and influencing a diverse range of groups in a fast-paced environment.
• Strong communication skills, both oral and written to effectively communicate technical information in a clear and concise manner within a GMP environment.
• Skilled at developing innovative solutions to plant challenges by applying problem-solving techniques and interpersonal strengths, while integrating insights from multiple functional areas.
• Proficient in MS Office (Word, Excel, Project, Outlook, etc.).