Validation Engineer

Catalent

Philadelphia,PA  

2019-09-30 2019-10-30
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











The Validation Engineer is responsible for the development, procurement, maintenance and implementation of procedures for the equipment and systems to ensure compliance with regulatory and internal quality system requirements, Corporate Policies and Standards, and current industry practice. This includes successfully working with other departments and contract resources to procure and manage, plan, and develop capital projects inclusive of new production equipment and facility expansions. Additionally, the Validation Engineer is responsible for assistance as required with acceptance of material based on cleanability, and is also responsible for customer communications where information related to validated systems is requested.







The Validation Engineer is expected to demonstrate leadership, knowledge, experience, personal drive, and creativity to ensure continuous progress on validation activities.







The role of the Validation Engineer is critical to the end user which are our patients. Processes need to be created and implemented with patient safety in mind, executing with efficiency always. Quality, safety and on-time delivery is a must to be successful in this role!







The Role





+ Develop, implement and maintain process validation procedures to current regulatory, industry, and corporate standards. Lead Validation Projects. Coordinate validation activities with Operations, Logistics, Engineering, and Project Management groups to ensure their efficient completion.



+ Prepare, review, execute and finalize process validation protocols supporting clinical packaging facilities, equipment, systems, the validation master plan, and cleaning validation.



+ Analyses Business Development request to determine equipment, tooling, or delivery systems needed.



+ Responsible for budgeting of projects and manages project expenditures through the CAR process.



+ Writes and executes Engineering/Validation protocols including URS, FAT, SAT, IQ, OQ, PQ.



+ Participates in the execution of SAT/FAT as needed. (May require some travel depending on the specific project.).



+ Writes CAR’s (Capital Appropriation Requests) for new equipment, including researching the justification.



+ Prepares project timelines and is responsible for meeting deliverables.









The Candidate





+ Bachelors Degree in Science or Engineering preferred or a minimum of 4 years in equivalent pharmaceutical GMP industry & validation experience required.



+ Ability to work well in a fast-paced environment, interfacing with internal and external customers, and meeting project timelines.



+ Statistical knowledge and ability to use applications such as JD Edwards, Minitab, jmp and/or Excel.



+ Strong technical writing skills and effective communication skills (verbal and written form).



+ Ability to coordinate, facilitate and organize resources.









Catalent’s standard 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





+ Lots of Growth/Development opportunities



+ 19 Days of PTO (Paid Time Off) per year



+ Tuition Reimbursement Program



+ Cross-functional exposure across Catalent













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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