Position Summary Validation Supervisor Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent. Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer’s. The Quality Assurance department is responsible for all aspects of the quality assurance functions at Catalent, Madison. The department’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients. The Validation Supervisor provides guidance and oversight for commissioning, qualification, and validation of systems and processes. The Validation group has oversight of the validation program, including commissioning and qualification, cleaning validation, and computer system validation as well as the activities required to maintain systems in a qualified and/or validated state, including change control, requalification, and system reviews. Provides guidance and oversight for commissioning, qualification, and validation of systems and processes. Shift: M-F 1st shift 8AM-5pm Location: Madison, WI 100% on site The Role: Drafts, reviews, and executes plans, protocols, and reports related to commissioning, qualification, and validation of systems and processes. This includes associated protocol events. Maintains systems and processes in the qualified and/or validated state, including performing and reviewing requalifications and periodic reviews. Reviews change controls to assess impact to commissioned, qualified, and validated systems and processes; Serves as a quality contact and subject matter expert (SME) for simple qualified and/or validated systems and processes. Implements improvements to established systems, processes, procedures, etc. to support quality management systems with oversight from management. Leads cross functional teams for initiatives around simple qualified and/or validated systems and processes; Independently oversees validation contractors; Provides technical assistance and training to personnel; Leads team members to improve and reinforce performance of others. Takes responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly. Works with, coaches, and supports direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee’s career development. Other duties as assigned. The Candidate: Doctorate Degree in STEM discipline with minimum of 2 years related experience, OR Master's Degree in STEM discipline with minimum of 4 years related experience, OR Bachelor's Degree in STEM discipline with minimum of 5 years related experience. Leadership experience required. Maintains data integrity and ensure compliance with company SOP’s, specifications, as well as cGMP, ICH, FDA, EMA regulations or guidelines; Ability to communicate complex technical information to non-technical audiences. Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution; Able to combine and interpret data from multiple disciplines and an understanding of the full Biologics process with respect to specific area of expertise. Uses comprehensive knowledge of applicable principles, concepts, and practices and/or techniques to lead projects within a department, group, or team in a single function or focus. Focuses on and regularly communicates to team about team priorities and sets aside identified less critical tasks; Makes implementation plans and assignments that allocate resources appropriately to complete objective. Maintains staff by recruiting and hiring employees, developing personnel growth opportunities, supporting employee motivation, and providing strategic alignment with Quality Assurance Department and site initiatives; Clarifies responsibilities and expectations and holds employees accountable; Participates in and conducts timely HR-related processes; Uses appropriate methods and flexible interpersonal style and coaching to develop others’ capabilities. Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening; Occasional stooping, kneeling, crouching, bending, carrying, grasping; Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds; Ability to operate within a clean room environment as needed. Why you should join Catalent: Defined career path and annual performance review and feedback process Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Dynamic, fast-paced work environment Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment 19 days of PTO 8 paid holidays Employee Stock Purchase Program Tuition Reimbursement GymPass program to promote overall physical wellness Perkspot - offers exclusive or private discounts from approximately 900 merchants in a wide array of categories 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. California Job Seekers can find our California Job Applicant Notice 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.