Manager Sr Manager, Facility Compliance in Gaithersburg, MD

$100K - $150K(Ladders Estimates)

Paragon Bioservices   •  

Gaithersburg, MD 20877

Industry: Pharmaceuticals & Biotech


5 - 7 years

Posted 52 days ago

Paragon Gene Therapy, in Baltimore, Harmans, Gaithersburg, & Catonsville, 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 of Facilities Compliance will report to the Vice President Facilities and Engineering. The role of manager is to provide leadership towards improving work force productivity and quality by anticipating and eliminating potential delays. Develop staff so they will be able to plan, schedule, and coordinate equipment maintenance. Accountable for the oversight of planning and coordination of all planned maintenance activities performed at the site occur. Provide regulatory guidance and GMP training to facilities 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 and the move from reactive to proactive maintenance work. This is a highly skilled position within the maintenance organization that requires prior experience with the equipment, processes, and workflow within the facilities.

Key Responsibilities include but are not limited to:

• Management of the planning, maintenance and compliance function for Facilities and Engineering

• Ensure that all facility utilities preventive maintenance is performed in accordance with cGMP guidelines.

• Maintain departmental industry compliance in support of GMP Manufacturing, Product Development administrative and laboratory activities.

• Ensure all work orders are completed and be able to prepare reports when asked. Consults with requester, maintenance supervisor, engineers or craftsman when necessary.

• Reviews, plans and schedules all recurring PM (preventive maintenance) activities

• Ensure all PM and repair activities are coordinated with manufacturing operations, purchasing, materials management, maintenance personnel and maintenance management

• Coordinates all Calibration activities with metrology team and manufacturing.

• Administrator of Blue Mountain calibration and maintenance software program.

• Ensure CMMS system is current and assist personnel in locating historical files.

• Manage plans for calibration and preventative maintenance of all GMP equipment, lab equipment, and utilities. Utilities to include clean steam, WFI, RO/DI water, boilers, compressed gases, HVAC systems, electrical, life safety, and emergency power system (UPS).

• Ensure plans and schedules for shutdowns are timely. (major and minor).

• Participate in client and regulatory audits, audit responses and follow up corrective actions when required.

• Communicate with senior leadership and Paragon personnel to bring them up to date on major repairs, planned and unplanned events that may disrupt manufacturing schedule.

• Lead compliance effort in facilities and engineering ensuring group operates in accordance to Paragon's cGMP quality system.

• Generate SOP's, deviations, and change control as required for related Facilities systems.

• Revise SOP's as required for updated systems and procedures

• Keep the leadership of Facilities and Engineering informed of abnormal or critical situations and seek advice on matters outside the Planner's knowledge or authority.

• Provide training on GMP compliance and CMMS to facilities and engineering staff.

• Ensure all state, federal, and local licenses and inspections are up to date.

• Manage, lead train and develop others effectively.

Experience & Education

• BS Degree in Engineering or relevant technical field

• 7 years of experience in a supervisor role

• 5 years of experience in a GMP / GXP quality system environment

• Experience leading cross functional teams in a fast-paced environment

• Hands on experience with CMMS software including Blue Mountain Regulatory Asset Manager

• Experience with Building Management software strongly preferred

• Good working knowledge of facilities equipment and O&M requirements

• Understanding of GMP compliance for facilities

• Strong understanding of proper OSHA safety practices and procedures

• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

• Ability to adapt in a constantly evolving environment

• Self-motivated with a strong sense of ownership in areas of responsibility.

Valid Through: 2019-10-18