Facility Compliance Specialist

Harmans, MD, US
Sep 26, 2019
Required Education
Bachelors Degree
Position Type
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with 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.

Paragon Gene Therapy, in Baltimore, Harmans, Rockville, & Gaithersburg, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.

The Facility Compliance Specialist will report to the Manager of Facility Compliance. The role of the specialist is to provide support for facility QA and provide regulatory guidance and GMP training to facilities and engineering teams in order to maintain a high level of quality and compliance. 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.

Responsibilities include but are not limited to:
• 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 Paragon'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.
• Provide training on GMP compliance.

Experience and Education:
• Bachelors degree in engineering or relevant technical field
• 3 or more years of experience with GxP Quality Systems
• Experience in cross functional teams in a fast-paced environment.
• Working knowledge of facilities equipment and O&M requirements
• Understanding of GMP compliance for facilities.
• Strong understanding of proper OSHA safety practices and procedures
• Great attention to detail
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.