Catalent Pharma Solutions Validation Manager in Massachusetts
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 (http://www.catalent.com/index.php/about-us/Catalent-Careers2)
The Boston-area facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.
The Validation Manager is responsible for leading a validation team to support all validation activities at the Catalent Boston site. Validation activities include equipment, instrument, cleaning, computer and process validation. The job includes writing, tracking, and coordinating protocols, reports, compiling data/attachments into comprehensive validation packages. Lead the development of procedures, specifications, validation master plans and other validation related documentation. This individual will participate in facility design, equipment specification, optimization and troubleshooting of equipment and processes.
The Role (daily responsibilities)
Lead all validation activities in a hands on approach in collaboration with the Engineering and Quality teams.
Work on multiple validation projects simultaneously and coordinate test work.
Lead FATs and SATs as appropriate for facilities, utilities and equipment.
Develop commissioning and qualification protocols for manufacturing, utilities, lab equipment and processes
Plan, coordinate and track the progress of validation projects
Incorporate continuous process improvements into the validation lifecycle
Compile validation packages and assure all required documentation is complete
Lead investigations related to validation deviations and assure thoroughness of investigation, documentation and closure
Write, review and approval of technical documents and reports such as protocols, SOPs, filing documentation and other cGMP documents
Train personnel to write, execute and summarize studies and oversees work
Maintain strict deadlines to minimize impact to production and maximize equipment/process efficiency
Participate in equipment/process design and specification of use requirements and factory acceptance testing
The Candidate (requirements)
BS in Engineering, Chemistry, Biology or related science
5+ years of validation experience in a cGMP manufacturing environment
Minimum of 3 years of previous leadership experience in a related field
Excellent working knowledge of cGMPs and regulatory requirements is required
Experience applying ASTM 2500 Standard and ISPE Baseline guides
Ability to generate GMP documentation to a high standard in relation to validation activities including SOP’s, protocols, reports and risk assessments.
Self-starting with demonstrated ability to successfully delegate work to a team.
Excellent communication skills, organizational skills and computer skills.
Ability to change priorities in response to company demands while continuing to deliver results
Strong work ethic; ability to excel in a fast paced, multiproduct environment
Demonstrated ability to work/collaborate within teams while interfacing with both internal and external colleagues
Strong knowledge and understanding of current Good Manufacturing Practices (cGMP) and FDA 21 CFR Part 210, 211 regulations and standards
Knowledge of calibration methodology, equipment, and instruments.
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
Competitive medical benefits and 401K
19 days of PTO + 8 paid holidays
Opportunity to make your mark on the validation processes at Catalent Boston
State of the art facility with new exciting equipment
Chelsea, MA site is conveniently located next to the train line
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 is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
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.
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 (https://catalent.wd1.myworkdayjobs.com/External) 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 (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .
Catalent Pharma Solutions
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