Catalent Pharma Solutions Validation Engineer in Woodstock, Illinois
Catalent is looking to recruit a Validation Engineer to join a growing Quality team in Woodstock, IL.
The Validation Engineer will be instrumental in the design, schedule, execution, and evaluation of scientifically and statistically sound qualification experiments. These experiments define and demonstrate that critical Cleaning, Controls, Equipment, Facilities, Processes, and Utilities function in a consistent and repeatable manner, in accordance with a host of regulations and policies affecting final product integrity.
Additionally, the Validation Engineer will assist the Validation department in developing policies, programs, SOPs, and Quality standards to meet current industry, corporate Quality, and external Regulatory requirements.
In concert with Catalent’s Patient First philosophy, this role is paramount to ensure the efficacy and quality of our manufacturing processes which will ultimately yield safe drug products for patients.
Prepare detailed, concise documentation dossiers on completed studies that summarize the experimental results, specifications, and conformance to defined acceptance criteria
Serve as the validation project manager representative on cross-functional project teams
Research governmental regulatory requirements on assigned projects to ensure that each study subject is challenged to meet required specifications
Prepare scientifically sound Validation Study Protocols that incorporate the defined specifications into acceptance criteria and assessment procedures
Maintain close contact with New Product Development, Engineering, and Manufacturing groups to assure effective communication on challenges and opportunities related to validation
Utilize and have knowledge of process equipment including Blow-Fill-Seal instrumentation, Industry standard pouching equipment, Checkweigher, Tanks, Industry Standard Leak Inspection Equipment
Bachelor of Science in Mechanical or Chemical Engineering
A minimum of one year validation experience within a pharmaceutical manufacturing operation or three years’ experience in pharmaceutical operations; Validation experience within aseptic manufacturing operations preferred
Demonstrated experience with cleaning validation and requalification of equipment
Knowledge of cGMPs, pharmaceutical manufacturing methods, and validation principles
Ability to thrive in a fast-paced environment and adapt to changes with a positive attitude
Catalent’s standard leadership competencies that are used to interview and for Performance & Development
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
Potential for career growth within an expanding Quality team
Defined career path and annual performance review & feedback process
Cross functional exposure to other areas of Quality and Production
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.
Catalent. More products. Better treatments. Reliably supplied. ™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 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.
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.
Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.
Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.
We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.
Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.
Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.
Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.
We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.
We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.
Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.
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.