Senior Validation Manager
2 weeks ago
PL Developments is seeking a highly experienced Senior Validation Manager to lead and manage validation teams, ensuring compliance with regulatory requirements and company policies. The ideal candidate will have a strong background in validation and quality assurance, with a proven track record of implementing validation strategies and managing cross-functional teams.
Key Responsibilities:
Manage and execute activities related to equipment, facilities, utility qualification, process, and cleaning validation.
Generate, execute, and review validation and qualification protocols per related Standard Operating Procedures (SOP's), Risk Assessments, and assure that acceptance criteria related to validation and qualification protocols are met.
Requalify existing equipment/processes as part of the lifecycle management of the product.
Support the development of best and proven validation practices in the validation department utilizing current industry guidelines and practices.
Investigate exceptions and protocol deviations to determine the impact on the validation.
Participate in cGMP audits as a validation subject matter expert.
Provide advice and counsel to the site Leadership Teams and Director, Corporate Validation on validation compliance issues and risks.
Requirements:
Bachelor's degree in Engineering, Science, or Quality preferred.
10+ years of experience in validation and quality, focusing on the liquids pharmaceutical industry.
Previous management/supervisory experience in validation or quality assurance.
Knowledge of OSHA and FDA guidelines, including 21 CFR Parts 111, 210, 211, and Part 11 Compliance.
Proven ability to lead and manage validation teams, including mentoring, performance evaluation, and career development.
Proficient with validation software and methods related to risk-based analysis, statistical process control, and process analytics.
Ability to develop and implement validation strategies aligned with company goals and regulatory requirements.
Expert level of Microsoft Office skills and experience in Oracle systems such as Agile PQM.
Strong interpersonal, written, and verbal communication skills for reporting, presentations, and interactions with regulatory agencies and other departments.
Proven track record with continuous improvement initiatives and successful CAPA implementation.
Strong analytical and problem-solving skills related to complex validation investigations.
What We Offer:
Competitive salary range of $120-$130k DOE.
Opportunities for professional growth and development in a dynamic and innovative company.
Collaborative and supportive work environment with a team of experienced professionals.
Comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
Periodic travel to support validation activities at PLD sites.
How to Apply:
If you are a motivated and experienced Senior Validation Manager looking for a new challenge, please submit your resume and cover letter to [insert contact information]. We look forward to hearing from you
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