Catalent Pharma Solutions Quality Engineering & Validation Specialist in Harmans, Maryland
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 Quality Engineer & Validation Specialist is responsible for providing Quality oversight of Paragons Facilities and Equipment Quality Systems to ensure compliance with applicable US regulations, guidance's, industry standards and Paragon policies/procedures supporting the Phase I/II clinical and commercial GMP manufacturing of biological drug substance and drug product. The position will provide continuous improvement support to process, equipment, utilities and computer systems and serve as the key Quality resource for the Engineering, Facilities and Validation organizations.
Serve as the QA liaison with the Facility, Engineering and Validation organizations to support company goals, client projects, continuous improvement initiatives and as a general resource.
Review and approve Protocols and Summary Reports for Equipment Installation/Operational/Performance Qualifications (IQ/OQ/PQ) used in the manufacture of cell banks, biological drug substance and parenteral drug product in a multi-product facility. Examples of equipment includes bioreactors, chromatography systems, controlled temperature units, filling/stoppering machines, autoclaves and critical utilities as well as Cleaning Verification (CV) Studies, Aseptic Process Simulation Studies, Sterilization Validations, Temperature Mapping Studies and other miscellaneous validation activities. Support review of the facility Validation Master Plan (VMP).
Support the Computerized System Validation Lifecycle to ensure compliance to 21 CFR Part 11, Eudralex Annex 11 and applicable FDA/EMA Guidance's on electronic data integrity. Review and approval of User Requirement Specifications (URS), Computerized System Risk Assessments, 21CFRPart 11/Annex 11 Assessments, Protocols, Test Scripts, Summary Reports and other applicable documentation.
Provide QA support of the Calibration Program, including review and approval of new calibration procedures, completed calibrations, and compliance to the calibration schedule. Review Out of Tolerances and support investigations evaluating product impact. Familiar with the use of electronic systems used for managing calibration programs such as Blue Mountain, including the review of electronic data, performing queries and printing reports.
Provide QA support of the Maintenance Program, including QA review and approval of Preventive Maintenance (PM) procedures ensuring their content and frequency are suitable for the intended application, entry of PMs into ProCal. Support other PM and responsive maintenance activities where needed.
Serve as QA resource supporting the facility and equipment change management program, including review of applicable change controls to ensure appropriate activities are performed and documented supporting the introduction or change to equipment and facilities.
Support the Risk Management Program to evaluate and mitigate risks associated with equipment and facilities as appropriate using tools such as Failure Modes Effects and Analysis (FMEA), Fault Tree Analysis (FTA) or other available risk management tools.
Bachelor’s degree in a Science or Engineering field with 5 years of experience - OR - Master's and 2 years
Experience supporting the quality assurance of validations associated to IQ, OQ & PQ's working primarily with the Facilities and Engineering teams for biologics manufacturing equipment.
Experience with aseptic processing required
Must have experience with biologics
Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
Key leadership attributes:
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Join a high growth and fast paced organization with a people focused culture
Global exposure, defined career path and annual performance review and feedback process
Competitive Medical, Dental, Vision and 401K
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.
C atalent 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) .