• Cleaning Validation Supervisor - 1st shift

    Catalent Pharma SolutionsBloomington, IN 47407

    Job #1011460526

  • Job Description

    Position Overview:

    Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

    Cleaning Validation Supervisor - 1st Shift

    Position Summary:

    Catalent is seeking a Cleaning Validation Supervisor to join our growing Validation team in Bloomington, Indiana.

    Our Validation Supervisors are tasked with establishing validation policies/strategies to manage projects for biopharmaceutical manufacturing equipment, manufacturing process and laboratory documentation ensuring the deliverables meet the quality standards and requirements of Catalent's policies and FDA regulations.

    There is a significant opportunity to learn, develop, grow, trying new things and personally impact the business, our clients and ultimately the patients receiving the lifesaving products we manufacture.

    In concert with Catalent's Patient First philosophy, your role is paramount to ensure the efficacy and quality of our manufacturing processes which will ultimately yield safe drug products for patients.

    In This Role

    • You will be managing multiple projects to provide documented validation of cleaning and release of equipment for manufacturing processes

    • You will establish philosophy, structure and scope in compliance with regulatory requirements through Validation Master Plans, policy and SOP's for cleaning validation

    • You will manage the activities and mentor 5+ direct reports to accomplish the scope of work within the validation department including hold and release tags, protocols and report development, execution of cleaning validation activities, and reviewing of Change Controls and regulatory filings.

    • You will evaluate and determine required validations testing, coordinating contract commissioning and validation services including contract review and approval as well as overseeing the implementation of laboratory validation requirements.

    • You will assigns jobs and monitors progress to ensure that duties are adequately carried out.

    The Candidate

    • HS Diploma or GED, Bachelor's degree in STEM is preferred

    • 0-1 years of leadership experience, 3+ years preferred

    • 1 year of GMP experience, 3+ years preferred

    We will identify candidates based on the following:

    • Leads with Integrity and Respect

    • Delivers Results

    • Demonstrates Business Acumen

    • Fosters Collaboration and Teamwork

    • Champions Change

    • Engages and Inspires

    • Coaches and Develops

    Position Benefits

    • Potential for career growth within an expanding team

    • Defined career path and annual performance review & feedback process.

    • Cross functional exposure to other areas of Manufacturing and Operations

    • 152 hours of Paid Time Off per year

    • Medical, dental, and vision insurance, as well as company matching 401k

    • On-site fitness center and wellness programs

    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.

    personal initiative. dynamic pace. meaningful work.Visit ~~~/careers to explore career opportunities.

    Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.

    Paragon Gene Therapy, a unit of Catalent Biologics, in Baltimore, Maryland is a leading viral vector development and manufacturing partner in the rapidly expanding gene therapy market. To browse career opportunities in Maryland, click here.

    Catalent = Catalyst + Talent

    Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

    personal initiative. dynamic pace. meaningful work.

    Catalent is the perfect place to grow your career if...

    • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

    • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year - more than any branded drug maker in the world!

    • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

    • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

    • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!

    • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.

    Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to ~~~. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.