Co-op: Validation

Catalent

Bloomington,IN  

2019-12-09 2020-01-08
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











Catalyst + Talent



A Catalent co-op offers you countless opportunities to have direct impact on the health and well-being of millions of people globally! Your passion for learning coupled with Catalent’s superior technologies will help drive the advancement of medicine in collaboration with leading pharmaceutical, biotech and health care innovators.







The Catalent Co-Op Experience includes:





+ Opportunity to make an impact in the lives of patients all over the world!



+ Experience through hands-on projects that support more superior drug development and delivery technologies than anyone else.



+ Exposure to top-tier scientists and industry leaders



+ Commitment from dedicated managers and mentors who are advocates for your success and career development



+ Access to collaborative and highly engaged colleagues across the globe excited to share their knowledge and provide you support









The Role



The Co-op program within the Validation department consists of five teams; Equipment/Facility Validation, Process Validation (PV), Cleaning Validation (CV), Quality Engineering (QE), and Computer System Validation (CSV). The equipment/facility team initially qualifies and maintains the qualified state of all equipment, facilities, and utilities. The process validation team facilitates at-scale mixing and hold studies, qualifies new products, and maintains the media fill program. The cleaning validation group qualifies equipment used to remove product from manufacturing parts, qualifies cleaning methods, and performs routine TOC testing. The CSV group qualifies new computer systems and changes to computer systems.







All teams support the manufacture of biopharmaceutical products and often require direct contact with clients and internal customers across the site. Successful candidates will have excellent communication skills, be self-motivated, and action oriented. This department requires individuals to independently problem solve, take ownership of their projects, and drive to meet deadlines. There is significant opportunity to learn, try new things and personally impact the business, our clients, and ultimately patients taking the life-saving products we manufacture.







Responsibilities will include:



Process Validation





+ Assist with process validation floor support for collecting manufacturing batch sampling for Mixing, Hold, and process performance qualification (PPQ) studies.



+ Author, execute, and summarize component compatibility operational qualification (CCOQ), component criticality integrity testing (CCIT), Mixing, Hold, and process performance qualification (PPQ) studies



+ Author and summarize component assessments for filling component



+ Support execution of PPQ readiness checklists









Equipment Validation





+ Author, execute and summarize new equipment qualifications



+ Execute and summarize annual equipment requalification's



+ Support with data mining of various past qualifications for technical rationales









Quality Engineering





+ Analyze and summarize process parameters within the Continued Process Verification (CPV) Program.



+ Author, execute and summarize Annual Product Review (APR/ PPQE) in order to verify consistency of existing manufacturing process.



+ Conduct Gauge R&Rs and Failure Mode Effects Analysis









Cleaning Validation





+ Prepare swab kits for cleaning validation studies



+ Perform testing for cleaning validation studies



+ Perform documentation reviews for cleaning validation studies



+ Execute cleaning validation studies alongside Manufacturing in both Drug Substance and Drug Product.



+ Creating testing protocols for cleaning validation studies.



+ Participate in process improvement projects with cross-functional teams for both Drug Substance and Drug Product.









Computer System Validation:





+ Author, execute, and summarize new computer system qualifications.



+ Support with data mining for periodic qualification evaluations (system reviews).









The Candidate





+ Currently enrolled in a College or University



+ Must be an undergraduate student in a STEM discipline or related field of study



+ Eligible to legally work in the United States



+ Able to work full time (40 hours/week)









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













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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