**Senior Engineer, Process Validation** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent Cell & Gene Therapy is a growing Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Catalent provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a Catalent employee, you will actively contribute to the delivery of our services and products to our customers and their patients. Catalent Pharma Solutions in Harmans, MD is hiring a Senior Process Validation Engineer who is responsible for the qualification of cGMP manufacturing equipment cleaning processes and/or manufacturing processes. It is critical to our patients as this individual will validate critical processes supporting our expansion and growth. **This is a full-time, salaried role. This is on site, no remote or hybrid work. The core hours are 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** + Responsible for Cleaning Validation and/or Process Validation: + Generates, reviews, and approves qualification protocol(s), for various processes in the facility; + Assure GxP operations are executed in compliance with applicable guidelines and regulations through quality risk management, risk assessment, and auditing functions; + Establish and report on key performance indicators, including use of a compliance index, to support quality compliance awareness, initiatives, and resource allocation; + Strategy reviewer of quality system documents including but not limited to CAPA, change controls, investigations, and deviations; + Ensures the timely completion of all applicable validation documentation, including coordination of contractor activities; + Works closely with Manufacturing, QA/QC, MS&T and Facilities & Engineering in determining the approach to the execution of validation activities, as applicable; + Maintains the validation program for process qualification, and/or cleaning verification/validation activities; + Provide SME level support to the manufacturing areas as required to assist in problem solving and long term changes that provide product/process improvements in relation to process failures; + Performs duties related to Corrective and Preventative Action (CAPA) plans, deviations and change control; + Prepares summary, deficiency and discrepancy reports, gap analysis, risk analysis and FMEA; + All other duties as assigned; **The Candidate** + Bachelor of Science in Engineering or Science Discipline required; + A minimum of five (5) years of validation experience in a GMP environment (GMP / Bio-Pharma/ Biotechnology); + Experience leading a successful PPQ campaign is highly desirable; + Demonstrated use of problem solving and continuous improvement techniques: + Knowledge of documentation practices associated with cGMP operations (SOPs, batch records, calibration and maintenance records, equipment logbooks, change control, etc.); + Work to targets and deadlines (planning, organizational and prioritization skills); + Ability to switch focus to support ongoing manufacturing operations in a dynamic environment; + Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds; **The Pay** + The anticipated salary range for this position in Maryland is $93,280-$128,260 and annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states **Why you should join Catalent:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + 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 + 152 Hours + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + Company match on donations to organizations + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement – Let us help you finish your degree or start a new degree! + WellHub 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. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .