Our client, a leading pharmaceutical company, is hiring a Facility and Reliability Engineer on a contract basis.
Work Location: Warren, NJ
The main purpose of the Facility and Reliability Engineer is to maintain a continuous improvement strategy to ensure the Warren, New Jersey site remains in a qualified and GMP-compliant operational state. The Facility & Reliability Engineer supports the successful operation of facility, laboratory, and business functions at the Warren, New Jersey site through interaction with internal customers and external service providers.
The individual is expected to represent the GMP Facilities Department on multi-disciplinary and cross-functional teams and must be able to influence key stakeholders with fact-based, business value knowledge. Collaborative work is required to support ongoing compliance efforts within the GMP Facilities department.
The individual is expected to be able to identify problems, compliance gaps, and unmet needs of moderate scope and complexity, and develop clearly structured plans of action to drive resolution. To be successful in this role the individual must adhere to specific job tasks and processes at both the site and the corporate level.
• Strong understanding of critical building & utility systems including life-safety, lighting, mechanical, electrical, plumbing, clean rooms, compressed gases, security, and site access.
• Experience with diagnosing equipment and environmental alarms via building automation and facility management systems.
• Experience writing maintenance plans for facility and lab equipment in a GMP-regulated computerized maintenance management systems (CMMS).
• Experience performing FMEA to assess equipment and process risks to the business.
• Must be able to utilize Lean/Six Sigma methodologies to build a clear path forward when solving problems and conducting investigations.
• Ability to quickly learn internal training, quality, and compliance computer systems.
• Ability to effectively communicate with employees, contractors, and vendors through well-
formulated emails and technical documentation.
• Ability to read, interpret, and revise technical manuals and engineering drawings relevant to the assigned task.
• Must be a self-starter who can follow oral and written instructions to work both independently and as a member of a cross-functional team.
• Familiarity with FDA / cGxP environments and associated compliance challenges.
• Knowledge of FDA & GMP regulations, IBC/IFC building codes, OSHA, NFP, FM, LPDS and UL.
• Technical writing
• Proficiency in MS Office
• Failure Mode Effects Analysis (FMEA) for Equipment and Processes
• Problem Solving
• Technical Troubleshooting
• Team Player
• Customer Focused
• Action Oriented / Tenacity
• Lean/Six Sigma Principles (6S/DMAIC/5-why)
Education & Experience
• BS degree in mechanical engineering, electrical engineering, or similar engineering field.
• Minimum 3-5 years of facilities maintenance/operations experience at an industrial or commercial site and/or equivalent combination of education and experience.
• Minimum 3 years of performing investigations within a GMP-qualified quality system.
• 2-5 years of GMP facility experience preferred.
Key Areas of Responsibility
• Initiates and supports deviations, investigations, and corrective/preventive action (CAPA) to drive resolution and close site-level compliance gaps.
• Investigates Facilities Department deviations to determine root cause and necessary CAPAs by working cross-functionally with site Manufacturing Operations, Supply Chain, Quality, and Engineering.
• Initiates deviations for maintenance work orders that are out of compliance.
• Promotes and maintains compliance with corporate safety, security, and regulatory policies.
• Completes all assigned Corporate, Facilities, GMP and EHS training in the Learning Management System within the first 30 days of the contract.
• Supports execution of the Corporate Reliability Program at the Warren site as needed.
• Reviews deviations, CAPA, and non-scheduled work orders to detect repeat issues and identify solutions that address the root cause to prevent further occurrences.
• Uses technical writing skills to establish effective preventative and predictive maintenance plans for GMP Facilities equipment as needed.
• Generates SOPs and Work Practices within Celgenes Document Management System to establish the Use, Maintenance and Calibration plans for GMP Facilities equipment.
• Works with internal & external partners to define vendor requirements to support maintenance or calibration plans.
• Promotes and upholds all client corporate values.
Facility Asset Management
• Review Bill of Material, OEM manuals, and OEM sequence of operations to generate a robust maintenance program for each asset.
• Provides technical expertise, troubleshooting and improved equipment maintenance & reliability strategies to optimize safe, compliant, and efficient operations of all GMP Facilities equipment and instrumentation.
• Prepares asset files including equipment data sheets, impact assessments, P&ID & drawings, factory O&Ms, factory maintenance recommendations, maintenance work plans and procedures.