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  • Facilities Compliance Specialist I - Severn - Disability Solutions

    Disability Solutions
    Disability Solutions Severn

    2 days ago

    Disability Solutions background
    Description
    Facilities Compliance Specialist I
    Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply.
    With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
    Catalent Cell & Gene Therapy is a growing Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Catalent provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need.
    As a Catalent employee, you will actively contribute to the delivery of our services and products to our customers and their patients.
    The Facilities Compliance Specialist I role reports to the Head of Facilities & Engineering. This position is responsible for providing regulatory guidance and GMP training to facilities and engineering teams to maintain a high level of quality. The role is a key member of a cross-functional team that supports the improvement of plant reliability. This is a skilled position within the maintenance organization that requires prior experience with equipment, processes, and workflow within the facilities.
    This is a full-time role with core hours of Monday – Friday 8:00AM – 5:00PM. The position sits onsite, with no remote work.
    The Role:
    • Ensure that all facility utilities preventive maintenance is performed in accordance with cGMP guidelines;
    • Generate SOP's, deviations, and change control as required for related Facilities systems;
    • Revise SOP's as required for updated systems and procedures;
    • Support compliance effort in facilities and engineering ensuring group operates in accordance to Catalent's cGMP quality system;
    • Maintain departmental industry compliance in support of GMP Manufacturing, Product Development administrative and laboratory activities;
    • Support client and regulatory audits, audit responses and follow up corrective actions when required;
    • Keep the leadership of Facilities and Engineering informed of abnormal or critical situations and seek advice on matters outside the specialist's knowledge or authority;
    • Provide training on GMP compliance;
    • All other duties as assigned;
    Requirements:
    • Bachelors degree in a technical field or equivalent experience required (Engineering preferred);
    • Minimum one (1) year of GMPP quality system experience in pharmaceutical or biotech industry required;
    • Willingness to think outside of the box and adapt best practices to increase efficiencies;
    • Experience in cross-functional teams in a fast-paced environment;
    • Understanding of GMP compliance for manufacturing facilities required;
    • Understanding of proper OSHA safety practices and procedures;
    • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
    • High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
    • Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;
    Why join Catalent?
    • Defined career path and annual performance review and feedback process;
    • Diverse, inclusive culture;
    • Positive working environment focusing on continually improving processes to remain innovative;
    • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives;
    • 152 Hours + 8 paid holidays;
    • Several Employee Resource Groups focusing on D&I;
    • Dynamic, fast-paced work environment;
    • Community engagement and green initiatives;
    • Generous 401K match;
    • Company match on donations to organizations;
    • Medical, dental and vision benefits effective day one of employment;
    • Tuition Reimbursement – Let us help you finish your degree or start a new degree;
    • WellHub program to promote overall physical wellness;
    • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories;

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