Engineer III – Validation

Summary

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.

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 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.        

This is a full-time on-site position, Monday – Friday 8:00am-5:00pm.

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:

Assists with maintaining Commissioning, Qualification, and Validation Master Plans and supporting procedures in alignment with industry standards and corporate policies.Provides guidance and oversight for commissioning, qualification, and validation of simple systems and processes.Drafts 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 requalifications and periodic reviews.Assists with Validation topics during internal audits, including participating during audits, providing responses to audit observations, and completing corrective actions.Serves as 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.Participates on cross functional teams to support initiatives around qualified and/or validated systems and processes.Oversees validation contractors with oversight from management.Provides technical assistance to personnel.Files and maintains controlled documents.Performs other duties as assigned.

The Candidate:

Master’s degree in STEM discipline with a minimum of 1 year related experience ORBachelor's Degree in STEM discipline with a minimum of 4 years related experience ORAssociate’s degree in STEM discipline with a minimum of 8 years of related experienceGMP experience Highly preferredAbility to communicate effectively and follow/retain detailed written and verbal instructions in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, professionally and accurately. Detail-oriented and well-organized with the ability to work effectively under high pressure with multiple deadlines. Ability to make decisions that have a moderate impact on immediate work unitAbility to see and hear and read and write clear English.  Ability to use Excel, Word, and other office systems.  Ability to learn and use quality management software. Ability to manage time effectively to complete assignments in the expected time frame and independently seek out additional work when tasks are completed ahead of time. Ability to contribute to investigations, deviations, and change controls with initial consultation from the supervisor. Ability to problem solve and execute and monitor corrective actions. Requires frequent sitting, standing, walking, reading, computer use, and occasional physical activities such as lifting up to 50 pounds, with compliance to EHS responsibilities and ability to work in HVAC-controlled and clean room environments.

Why you should join Catalent:

Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of paid time off annually + 8 paid holidays Competitive salary with yearly bonus potential Community engagement and green initiatives Generous 401K match and 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. 

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.

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