QRM/Contamination Control Strategy/Cleaning Validation Specialist

Location: Carolina, PR · Biotech/Pharmaceutical Industry

Job Overview:
We are seeking a skilled professional to support the Quality Risk Management (QRM) program, Contamination Control Strategy (CCS), and Cleaning Validation activities at a pharmaceutical manufacturing site. The ideal candidate will provide technical leadership for risk assessments, cleaning validation, contamination control documentation, and compliance with regulatory and corporate quality standards.

Key Responsibilities:

• Lead Quality Risk Management (QRM) exercises utilizing tools such as FMEA to define Environmental Monitoring sampling locations and contamination control strategies.
• Serve as Subject Matter Expert (SME) for the development and execution of cleaning validation protocols, reports, and instructions.
• Participate actively in project team meetings (Cleaning Validation, Contamination Control Strategy) to provide technical input and escalate issues as needed.
• Author and implement risk assessment reports and cleaning validation documentation to ensure GxP and data integrity compliance.
• Conduct triage assessments to determine change control requirements and lead/support Change Control Board submissions.
• Review and revise documentation associated with contamination control strategies and cleaning programs, including SOPs, master plans, protocols, reports, and sampling schemes.
• Deliver training sessions to manufacturing operators related to cleaning processes and contamination control standards.
• Ensure compliance with regulatory and corporate standards, including cGMP, safety, security, and environmental policies.
• Complete all required compliance and qualification training (Darwin, Trackwise, VEEVA systems).
• Support additional tasks and initiatives as assigned by the supervisor.

Required Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related field preferred. Associate’s degree with extensive relevant experience may be considered.
• 3+ years of experience in pharmaceutical manufacturing, with strong knowledge of cleaning validation and quality risk management.
• Hands-on experience with Quality Risk Assessment tools (e.g., FMEA).
• Strong technical writing skills for developing validation protocols, reports, and risk assessments.
• Working knowledge of GxP, cGMP, and data integrity principles.
• Proficiency with electronic quality management systems (Trackwise, VEEVA, etc.).
• Excellent organizational, communication, and teamwork skills.
• Bilingual (English/Spanish) preferred.

Preferred Qualifications:

• Experience leading Contamination Control Strategy (CCS) projects.
• Familiarity with regulatory audits and inspection readiness activities.
• Experience presenting at Change Control Boards or Quality Committees.

Weil Group is proud to be an Equal Employment Opportunity Employer.