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 proceduresExcellent 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 states

Why you should 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 innovativePotential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 Hours + 8 paid holidaysSeveral Employee Resource Groups focusing on D&IDynamic, fast-paced work environmentCommunity engagement and green initiatives Generous 401K match Company match on donations to organizationsMedical, 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

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. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.