Manager, Facilities Certifications

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Title: Manager, Facilities Certifications

Location: Warren, NJ

The candidate will serve as the site certification program owner/SME for BSCs, PCR hoods, utility gas systems, and GMP rooms. Additionally, the candidate will support the execution of asset management and CTU requalification deliverables. The role requires knowledge of GMP facilities practices and project management skills. This individual works independently to successfully complete tasks on time and provides project, routine, and on-demand support for the facilities and engineering department.

Key Responsibilities:

• Owner of the site certification program for BSCs, PCR hoods, utility gas systems, and GMP rooms.
• Manage 3rd-party vendors to execute certification work in a safe and efficient manner.
• Manage routine BSC and isolator airflow visualization studies.
• Supports project engineering as SME for site certification program requirements.
• Owner of the DART (Daily Alarm Response Triage) meetings.
• Cross-functionally assesses impact, of priority 1 alarms, w/impacted departments and QA leading to the completion of cleaning/remediation activities.
• Supports site asset management team with SOP drafting/reviewing, PM plans, and asset induction deliverables.  
• Supports plant engineering w/reviewing facility drawings.
• Initiates and manages change controls.
• Supports CTU requalification activities such as drafting, executing, and reviewing protocols.
• Draft and route documentation required to activate CTU equipment (PM plans/WPTs/impact assessments).
• Initiates and manages deviations, investigations, and corrective/preventive action (CAPA) to drive resolution and close site-level compliance gaps.
• Manages facilities and engineering compliance events/actions, ensuring on-time completion.
• Investigates deviations to determine root cause and necessary CAPAs by working cross-functionally with site Manufacturing Operations, Supply Chain, Quality, and Engineering.
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Qualifications & Experience:

• Bachelor’s degree required; preferably in engineering
• Minimum of 3 years of experience managing BSCs, PCR hoods, utility gas systems, and GMP room certifications for ISO class 5, 7, and 8 environments.
• Minimum of 3 years managing 3rd-party vendors or direct reports.
• GMP facility experience required.
• Strong knowledge of facility engineering principles associated with requirements for BSCs, PCR hoods, utility gas systems, and GMP room certification for ISO classes 5, 7, and 8 environments.
• Ability to effectively manage multiple projects/tasks simultaneously in conjunction with proven organizational skills. • Ability to organize assigned projects/tasks, in a high paced GMP environment, and cross-functionally work with other departments to ensure on-time completion.
• Familiarity with FDA / cGXP environments and associated compliance regulations.
• Adept in Microsoft Office Suite – Word, PowerPoint, Excel and Outlook, and the ability to learn new software, such as enterprise business, building management, security, and maintenance management systems.
• Proficient at writing well-formulated emails and notifications. Ability to effectively communicate with employees, contractors, and vendors.
• Self-starter who is able to work both independently without direct supervision and in a team environment.
   

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