Contamination Control Specialist

This Contamination Control Specialist is the site SME responsible for coordinating all cleaning validation and verification activities related to intermediate and API manufacturing, including facility surfaces and equipment. This role involves close collaboration with various departments to ensure compliance with regulatory and customer requirements while implementing effective cleaning strategies across the site. The position is integral to maintaining quality and safety standards in the manufacturing process, supporting both current operations and customer needs. The role is also responsible for managing the environmental and purified water monitoring programs to ensure product quality and safety throughout the manufacturing process.

Core Responsibilities: 

• Contamination Control
  • Develop, implement, and maintain contamination control strategies and programs to ensure the protection of product quality in manufacturing environments.
  • Monitor and evaluate the effectiveness of existing contamination control systems (including air handling systems, HVAC, and microbiological controls).
  • Perform routine environmental monitoring in across manufacturing facilities to assess microbial and particulate contamination.
  • Assess, review, and improve cleaning, environmental and contamination control procedures to meet GMP, regulatory, and internal standards, including conducting risk assessments and implementation of risk mitigation strategies.
  • Establish contamination control metrics and key performance indicators (KPIs) to track and report progress against site goals.
• Cleaning Validation:
  • Lead the development, execution, and validation of cleaning procedures for equipment, production lines, and facilities.
  • Write and review cleaning validation protocols and reports in compliance with regulatory requirements, ensuring that all materials are free of any residues or contaminants.
  • Coordinate and conduct sampling (e.g., swab, rinse, and surface) and analytical testing to validate cleaning processes and confirm cleaning effectiveness.
  • Develop and maintain cleaning validation schedules to ensure timely completion of required validations
  • Review cleaning validation data, ensuring it meets established acceptance criteria, and make recommendations for process improvements.
• Environmental Monitoring & Purified Water Monitoring:
  • Oversee and manage the environmental monitoring program, ensuring compliance with established guidelines for monitoring particulate, microbial, and endotoxin levels in manufacturing and critical areas.
  • Review and interpret environmental monitoring data and identify trends or excursions, initiating corrective actions or investigations as needed.
  • Develop and implement strategies to prevent contamination and maintain a suitable environment in manufacturing and processing areas.
  • Oversee the purified water (PW) monitoring program, ensuring compliance with quality standards for water used in pharmaceutical intermediate and API manufacturing.
  • Conduct routine sampling, testing, and analysis of purified water systems to ensure that water meets pharmacopeial standards (e.g., USP or EP) for microbial quality, endotoxin levels, and other relevant parameters.
  • Investigate and troubleshoot any deviations or issues with purified water quality, implementing corrective actions and ensuring the integrity of water systems.
• Compliance & Documentation:
  • Ensure all contamination control, cleaning validation, environmental monitoring, and purified water monitoring activities are fully compliant with applicable cGMP guidelines, FDA, EMA, ICH, and other regulatory requirements.
  • Review and approve standard operating procedures related to cleaning, environmental monitoring, and water systems to ensure they meet regulatory standards.
  • Prepare and maintain detailed documentation of cleaning validation protocols, deviations, change controls, EM and PW monitoring results, and corrective and preventive actions.
  • Provide support during regulatory inspections and audits, addressing any findings or questions related to contamination control, cleaning validation, or monitoring programs.

Qualifications: 

Required

• Minimum 7 years of quality assurance experience with an undergraduate degree in engineering, science or related field or
• Minimum 5 years of quality assurance experience with a graduate degree in engineering, science or related field or 
• Minimum of 3 years of experience in contamination control, cleaning validation, environmental monitoring, and/or purified water systems, preferably in a pharmaceutical or biotech manufacturing environment (API CDMO experience is highly desirable)
• Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry
• Strong knowledge of cGMP, FDA, EMA, ICH guidelines, and other regulatory standards related to contamination control, cleaning validation, environmental monitoring, and purified water systems
• Experience with microbiological sampling, environmental monitoring, and testing of purified water systems in a regulated pharmaceutical environment
• Proficiency with risk assessment tools such as FMEA.
• Previous experience working in cross-functional and project-based environments.
• Experience creating metrics for driving continuous improvement
• Excellent analytical, written and verbal communication and presentation skills
• Hands-on experience with cleaning validation, TOC analysis, and bioburden reduction strategies
• The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently
• Experience in a fast-paced work environment
• Certification in contamination control (e.g., PDA Certification in Contamination Control).
• Knowledge of risk-based approaches to cleaning validation (e.g., Risk Assessment and ICH Q9)
• Experience with continuous improvement methodologies such as Lean or Six Sigma desire
• Familiarity with environmental monitoring equipment and purified water system design and validation
• Driven and detail-oriented, with a strong understanding of cGMP regulations and previous experience in cleaning validation