Manager, Facilities Maintenance

Employer
Paragon BioServices
Location
Hanover, MD
Posted
Jun 14, 2019
Closes
Jun 21, 2019
Ref
160892412
Hours
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, 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 Manager, Facilities Maintenance will be responsible for the overall facilities needs for both GMP and non GMP areas including Manufacturing, Product Development and Administrative buildings both existing and under design. Specifically, managing and executing the preventive maintenance, repairs, installation and calibrations on building utilities, HVAC, control systems, water and steam systems and process equipment (some within GMP compliance). The position directs the day-to-day activities of the maintenance & calibration teams to include training, security, pest control, maintenance, calibration, janitorial activities and associated contractors. Key Responsibilities include, but are not limited to: Ensure that all facility utilities are 100% operational and maintained in accordance with cGMP SOP's, maintaining departmental industry compliance in support of GMP Manufacturing, Product Development administrative and laboratory activities Lead, coach and mentor existing and new team members in both the maintenance and metrology teams supporting all shifts Set Expectations and ensure all contractors are compliance and meeting expectations regarding contracted obligations, training and enforce safety awareness and practices Recommend solutions and implements appropriate corrective actions for major and complex maintenance issues Administrator of Blue Mountain calibration and maintenance software program Startup and shutdown facility systems and upgrade associated utilities as required for new equipment installations Manage plans for calibration and preventative maintenance of all GMP equipment, lab equipment, and utilities such as clean steam, WFI, RO/DI water, boilers, compressed gases, HVAC systems, electrical, life safety, and emergency power system (UPS) Responsible for monitoring and responding to remote Critical Equipment Monitoring System notifications and take appropriate action per approved SOP's All Facility team are on call 24-7 Participate in client and regulatory audits, audit responses and follow up corrective actions when required Generate SOP's, deviations, and change control as required for related facilities systems Revise SOP's as required for updated systems and procedures Manage facility support contractors, including security. pest control, waste management fire systems, and landscaping Maintain up to date records for all state, federal, and local licenses and inspections Manage space planning, storage areas, and furniture purchasing/installations Education & Experience: HS Diploma/GED and 12 years experience in a Maintenance or Facilities role with some or all of that experience under GMP compliance Associates Degree and 10 years experience Bachelor Degree or more and 8 years experience Hands on maintenance/facilities experience with mechanical, electrical, HVAC, water systems & compressed gas systems Direct leadership experience across multiple shifts Experience writing, reviewing, editing SOP's and other compliance documentation 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. #LI-EW1

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