Senior Process Engineer

Catalent

Madison,WI  

2019-09-28 2019-10-28
engineer allied.health pharma

At Catalent, we recognize talent is our most important asset. Propelled by the passion to excel, we are committed to attracting, developing, and retaining talented and dedicated professionals who can help us deliver on our promise of more products, better treatments, reliably supplied.

From helping our customers produce world-class pharmaceutical products to identifying future technologies that will improve drug delivery, we achieve our amazing breakthroughs and innovations because of our talent!



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











Senior Process Engineer







Position Summary







Catalent is looking to recruit a Senior Process Engineer to join a growing team in Madison, WI.







The Senior Process Engineer will lead the tech transfer, scale up and process documentation required to transfer Phase I-III/Commercial processes from Process Development into Manufacturing. The Senior Process Engineer will be the subject matter expert for the production process activities including scale-up and technical process knowledge for specific programs. They will also manage specific client requests, attend client meetings and understands uniqueness of each process. The Senior Process Engineer will support the Program Managers and Commercial Readiness Team and drive the closure of process gaps. This position will also play a significant role in the technical support of the construction of an additional GMP operations suite.







In concert with Catalent’s Patient First philosophy, this role is critical to the safe and on-time delivery of our clients’ products to patients by providing guidance and oversight of well-defined and documented manufacturing processes.







***Please note that relocation assistance is available for the right candidate***







The Role





+ Recommends process scale-up of biological processes, leads gap analyses to identify key process parameters and equipment needs to facilitate process transfer into manufacturing.



+ Directs the development of a strong and robust Technology Transfer process (both internal and external) to support both clinical and late phase production.



+ Manages the authoring of Process Descriptions and Batch Records, support equipment, commissioning, process training, and validation activities.



+ Leads facility fit activities for existing and future internally and externally transferred processes.



+ Leads the process development component of the Commercial Readiness Team to ensure the facility and its processes are ready for Phase III / Commercial production.



+ Champions best practices and drives adoption into the manufacturing group to improve clinical and commercial production processes









The Candidate





+ Ph.D. in Biotechnology, or related field with at least 5 years of biopharmaceutical process development and manufacturing experience



+ MS in Biotechnology, or related field with at least 8 years of biopharmaceutical process development and manufacturing experience



+ B.S/B.A. in Biotechnology, or related field with at least 10 years of biopharmaceutical process development and manufacturing experience



+ Associates Degree/Certificate/Diploma in laboratory science with minimum of 15 years of biopharmaceutical process development and manufacturing experience









Catalent’s standard leadership competencies that are used to interview and for Performance & Development:





+ 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 Catalent



+ Medical, Dental, Vision, and 401K are all offered from day one of employment



+ 19 days of paid time off annually + 7 paid holidays

















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 www.catalent.com/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 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.





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 Jobs@catalent.com. 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.
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