Sr Process Validation Engineer

Company: Catalent
Location: Bloomington
Posted on: March 20, 2023

Job Description:

Sr Process Validation Engineer

Position Summary:

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.

A Sr Process Validation Engineer will participate in validation projects relating to Process Performance Qualification (PPQs), control strategy development, mixing and hold studies, manufacturing processes and new component and equipment qualification. The Validation Engineer will support the Equipment, Process and Cleaning Validation Team in all areas of the facility (Drug Substance, Drug Product Formulation/Fill/Finish and Inspection/Packaging)

This is a full-time role position: Monday - Friday, days.

Catalent Biologics in Bloomington, Indianais a state-of-the-art,GMP manufacturing facility,providing one millionsq/ft of drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives.

Catalent is committed to a Patient First culture through excellence in quality andcompliance, and to the safety of every patient, consumer, and Catalent employee.

The Role

• Coordinate multiple projects, documenting activities and summary report templates
• Perform Qualification activities such as controlled temperature units, CIP, SIP, Lyophilizers, Autoclaves, parts washers, terminal sterilizers
• Interact in a client facing position to support customer product launches
• Support capital expansion projects/build outs such as formulation suites, filling lines and packaging equipment
• Establish new templates, validation strategies and policies
• Review facility changes and provide input on re-validation
• Assessing risks involved in processing steps and related to equipment, developing and/or reviewing validation requirements and design deliverables
• Partner with contract validation teams to support and monitor efforts
• Monitoring validation strategies, ensure polices are followed, conducting validation studies in accordance with batch records/protocols
• Identify exceptions associated with validation protocol execution
  
  The Candidate
  
  • Bachelor's degree (required) in STEM discipline
  • 5-8 years of experience in Validation or related discipline
  • 1-year GMP experience preferred or other regulated industry
  • Competent at-risk mitigation for function
  • Previous direct contact with clients and internal customers (Customer Facing experience)
  • Excellent communication skills
  • Self-motivated and action oriented
    
    Why you should join Catalent:
    
    • Defined career path and annual performance review and feedback process
    • Diverse, inclusive culture
    • 19 days of PTO + 8 paid holidays
    • Dynamic, fast-paced work environment
    • Positive working environment focusing on continually improving processes to remain innovative
    • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
    • Competitive salary with quarterly bonus potential
    • Community engagement and green initiatives
    • Generous 401K matchand Paid Time Off accrual
    • Medical, dental and vision benefits effective day one of employment
    • Tuition Reimbursement
      Catalent 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.
      
      Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
      
      personal initiative. dynamic pace. meaningful work.
      
      Visit Catalent Careers 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 DisabilityAccommodations@catalent.com . 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.

Keywords: Catalent, Bloomington , Sr Process Validation Engineer, Engineering , Bloomington, Indiana