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Facilities Compliance Specialist I - Severn Maryland
Company: Disability Solutions
Location: Severn, Maryland
Posted On: 02/04/2025
Facilities Compliance Specialist I Position Summary: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.Catalent Pharma Solutions in Harmans, MD is hiring a Facilities Compliance Specialist I who will report to the Head of Facilities & Engineering.-- The role of Specialist is to provide regulatory guidance and GMP training to facilities and engineering team to maintain a high level of quality.-- This position 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 the equipment, processes, and workflow within the facilities.-- This is a full-time role. This position sits onsite, no remote work.-- The core hours are Monday - Friday 8:00AM - 5:00PM Catalent is committed to a Patient First culture through excellence in quality and--compliance, and to the safety of every patient, consumer, and Catalent employee.--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;The Candidate
- 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;The Pay
- The anticipated salary range for this position in Maryland is $73,000 - $90,000 plus shift differential and annual bonus, when eligible.-- The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other statesWhy you should join Catalent:
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