Process Validation Manager

Company: Disability Solutions
Location: Bloomington
Posted on: September 28, 2024

Job Description:

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.--The Validation strategy is to manage projects relating to biopharmaceutical manufacturing equipment, critical computer systems, manufacturing processes and documentation to ensure the validation deliverables meet the quality standards and requirements of company policies and FDA regulations.-- The Process Validation Manager's responsibilities include managing multiple projects to provide documented validation of manufacturing processes, establishing philosophy, structure and scope in compliance with regulatory requirements through Validation Master Plans, policy and standard operating procedures, managing the activities of direct reports to accomplish scope of work of validation department, managing protocol and report development, execution and approval associated with process validation, reviewing and approving documentation, evaluate and determine required validation testing, and validation services including contract review and approval, and overseeing the implementation of validation requirements.This is a fulltime role working days; Monday - Friday and requires flexibility to meet business needs. --Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.The Role

• Develop qualification strategies and documents for novel processes
• Train new team members and provide technical oversight of work performed by Technicians, Associate Engineers and/or Engineers; Ensures employees career development
• Takes responsibility for direct reports' performance by setting clear goals and expectations, coaching, supporting and tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly
• Formal client communications including client memos as required for process validation topics; Lead client meetings and response to client and regulatory requests and observations
• Review change controls for process impact
• Supervises Validation personnel with oversight from management, including assignments and priorities, providing guidance, and serving as a resource for technical and administrative issues
• Lead response to regulatory requests and observations as required
• Serves as a contact and subject matter expert (SME) for qualified and/or validated systems and processes
• Implements improvements to established systems, processes, procedures, etc. to support quality management systems with oversight from management
• Other duties as assignedThe Candidate
  • Bachelor's Degree, required
  • Master's Degree, preferred
  • 3-5 years of relevant leadership experience
  • 5 years GMP or other regulated industry experience, required
  • Possesses a strong understanding of guidance documents from FDA, EMA, PDA, ISPE, and other industry organizations
  • Understands validation technical disciplines, including equipment, cleaning, computer system validation, and process validation, and be able to integrate validation into broader projects
  • Must be able to read and understand English-written job instructions and safety requirements.Why You Should Join Catalent
    • Competitive medical benefits and 401K
    • 152 hours of PTO + 8 Paid Holidays
    • Dynamic, fast-paced work environment
    • Opportunity to work on Continuous Improvement ProcessesCatalent offers rewarding opportunities to further your career!-- Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.--personal initiative. dynamic pace. meaningful work.Visit to explore career opportunities.Catalent is an Equal Opportunity Employer, including disability and veterans.If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.--------Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

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