Sr Validation Manager - Lynwood CA

Piper Companies is currently looking for an experienced Sr Validation Manager in the Los Angeles, CA to work for an innovative and growing pharmaceutical company. Managing activities related to equipment, facilities, utility qualification, process, and cleaning validation

Responsibilities for the Sr Validation Manager include:

• Manage and execute equipment, facility, utility qualification, process, and cleaning validation activities.
• Develop, review, and approve validation and qualification protocols per SOPs and ensure that all acceptance criteria are met.
• Requalify existing equipment and processes as part of lifecycle management.
• Lead cross-functional teams to ensure successful project execution, focusing on compliance with regulatory standards.
• Investigate exceptions and deviations, determining impact on validation efforts.
• Provide advice on validation compliance to leadership teams and corporate directors.
• Plan, schedule, and manage cleaning and process validation studies, including authoring plans, protocols, and reports.
• Participate as a validation subject matter expert in cGMP audits.
• Ensure compliance with FDA, cGMP, and other relevant regulations and guidelines.
• Coordinate with R&D, operations, quality, and engineering teams to align project goals.
• Manage multiple projects utilizing project management methodologies.
• Evaluate and oversee external validation resources to ensure they meet internal policies.
• Maintain knowledge by attending workshops, networking, and participating in professional societies.

Qualifications for the Sr Validation Manager include:

• Prior management or supervisory experience in validation or quality assurance.
• In-depth knowledge of FDA guidelines, including cGMP, 21 CFR Parts 111, 210, 211, Part 11 compliance, and FDA Process Validation principles.
• Familiarity with OSHA standards and ICH Q9/Q10 guidelines.
• Proven ability to lead validation teams and mentor team members.
• Proficient with validation software, risk-based analysis, and statistical process control.
• Experience with Oracle systems, including Agile PQM.
• Strong communication, problem-solving, and interpersonal skills.
• Proven track record with CAPA implementation and continuous improvement initiatives.
• Expertise in Microsoft Office applications.
• Education: Bachelor's degree in engineering, Science, or Quality preferred.
• Experience: 5-10 years of validation and quality experience, with a focus on liquid pharmaceuticals.

Compensation for the Sr Validation Manager include:

• Competitive base salary, commensurate with experience.
• Comprehensive benefits package including medical, dental, vision, and retirement plans.
• Performance-based bonuses.
• Paid vacation and holidays.

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