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.

The Senior Cleaning Validation Engineer is responsible for participating in validation projects related to manufacturing equipment, critical computer systems, manufacturing processes and laboratory documentation to support the commercial GMP manufacturing of biological drug substance and drug product. Responsibilities include coordinating multiple projects and documenting activities via protocols and summary reports. This role will help establish cleaning validation strategies and policies, as needed, including reviewing quality control/method validation documentation, new product introduction and and providing input on re-validation, assessing risks involved in processing steps related to cleaning validation. This role will help develop and/or review cleaning validation requirements and design deliverables. This position is 100% on site 1st shift M-F at our Harmans/BWI, MD facility.

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
o Author and review cleaning validation policies, SOPs and/or protocols including, but not limited to visual inspection residue limits, swab/rinse recovery studies, spray coverage, and worst case residue assessments.
o Organize, schedule and track validation projects in order to meet client requirements/timelines; Participate in client meetings to help coordinate cleaning verification/validation activities
o Collaborate with Manufacturing, MS&T, Engineering and QA to develop clean/dirty hold time procedures; Conduct visual inspection and swab qualification programs for Manufacturing
o Perform validation testing and analyze data for validation documentation to determine acceptability, identify discrepancies and make appropriate notifications; Assist with updating/maintaining the site validation master plan and cleaning validation master plan; Support internal, regulatory and client audits for Validation
o Generate and modify cleaning procedures/work instructions for new products/new processes and/or existing manufacturing equipment; Lead and participate in the initial cleaning validation activity deliverables (i.e. scheduling, assessment training, documentation execution, issue resolution, reporting, etc.); Maintain the validated status of cleaning processes
o Provide technical support and expertise related to the cleaning process, critical quality attributes related to the output of the cleaning as well as critical cleaning agent parameters, process equipment assessment and analytical methods & recovery study
o Support the Validation Lifecycle to ensure compliance to 21 CFR Part 11, Eudralex Annex 11 and applicable FDA/EMA Guidances; Participate in investigations and preventive/corrective actions for Validation including authoring and/or reviewing/approving Change Controls, CAPAs and Deviations
o Other duties as assigned

The Candidate
o Bachelor’s degree in a Science or Engineering field required with 5 years of experience or similar experience highly desirable or Master’s degree in a Science or Engineering field with 3 years of experience
o Able to work in a team setting and independently under minimum supervision.
o Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks

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.