Lead Facility & Reliability Engineer
Newark Metro Area, NJ
The main purpose of the Lead Facility & Reliability Engineer is to implement a continuous improvement strategy to support the New Jersey GMP Facilities to maintain a qualified and regulatory compliant Facility Operation status. Main responsibility will be to oversee the maintenance and calibration plans for all GMP and Non-GMP utility equipment and instrumentation. The Lead Facility & Reliability Engineer will lead small-scale capital and expense projects (20K to 250K) and coordinate large-scale capital projects with Global Engineering to support the GMP facility operations within New Jersey. The incumbent in this role will have specific job tasks and processes to follow to perform their job. The Lead Facility & Reliability Engineer supports the successful operation of facility, laboratory and business functions at multi-use GMP sites within New Jersey through interaction with internal customers and external service providers. The role is expected to be able to identify issues or unmet needs and initiates projects or programs to address them. This individual works collaboratively to complete assignments and oversees the successful completion of tasks. Using solid analytical skills, the incumbent is able to recognize problems of moderate scope and complexity, and independently, develop potential solutions and courses of action. This individual represents the work group on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge.
Facility Asset Management
- Provides technical expertise, troubleshooting and improved equipment maintenance/reliability strategies to optimize safe, compliant, and efficient operations of all facility and utility 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.
- Assist in the development and management of a facility document management program to track facility drawings, and project turnover packages.
- Lead on facility workstream to support large-scale project asset and maintenance plan management. Project will require the ability to identify and manage contract support to execute according to project schedule.
- Manage logbook strategies for facility equipment owned and maintained by GMP Facilties.
Preventative Maintenance Work Plans
- Establishes effective preventative and predictive maintenance plans for GMP Pharmaceutical facility & process utility equipment according to OEM recommendations, industry standards and process application
- Generates SOPs and Work Practices within company s Document Management System to establish the Use, Maintenance and Calibration plans for GMP equipment.
- Works with vendors to define vendor requirements to support maintenance or calibration plans.
- Initiates deviations for maintenance work orders that are out of compliance
- Manages any CAPAs associated with the CMMS, including PMs or Calibrations performed late or out of conformance
- Reviews completed demand work orders for compliance with change control and like-for-like procedures
- Conducts Historical Performance Reviews on GMP Direct Impact assets and Critical instrumentation maintained and calibrated by the GMP Facilities Department
- Initiates deviations for demand maintenance work orders or preventative maintenance activities that are out of compliance
- Support and track deviations, investigations and CAPA plans for the GMP Facilities Department. Role will include conducting detailed investigations to determine root cause and necessary CAPAs by working cross functionally with Facility Management, QA, Validation and Business Area Management.
- Implement predictive maintenance tools to identify equipment trending to failure to implement repairs prior to failure.
- Support facility operations by providing operational SOPs to manage GMP facility and equipment operations. Procedures may include a USP Water System Operational Procedure or Facility Cleaning.
- Manages small scale capital projects (20K to 200K) to execute utility equipment upgrades, large scale repairs and replacements.
- Works with Facility Management to define requirements, SOWs, schedule, operational impacts and budgets to develop a project plan for small scale capital and expense project approval and execution.
- Coordinate with QA and Validation to initiate the necessary change controls and identify the qualification/ commissioning needs for small scale capital and expense projects.
- Coordinate larger scale facility capital projects with Global Engineering to act as a Facility Department liaison, to ensure project design considers facility standards, BOD/URS needs and operational requirements of the facility. Assist in coordinating the construction, start-up, training and commissioning/qualification activities for utility equipment with Facility operations.
- Oversee project engineering turnover documents to ensure accuracy of documentation, completeness and proper archiving.
Promotes and maintains compliance with corporate, safety, security and regulatory policies.
- Maintains all assigned Corporate, Facilities, GMP and EHS training as required
- Oversee the LOTO and Confined Space procedures for GMP Facility owned and maintained equipment.
Required Competencies-Knowledge, Skills, and Abilities:
Knowledge, Skills & Abilities:
- Strong understanding of building systems including life-safety, lighting, mechanical, electrical, and plumbing
- Strong knowledge of critical utility systems such as compressed gas, vacuum, waste, as well as security and key managements systems and policies
- Strong knowledge of facility management systems such as CMMS (Computerized Maintenance Management Systems).
- Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced GMP environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
- Familiarity with FDA / cGXP environments and associated compliance regulations
- Adept in Microsoft Office Suite Word, PowerPoint, Excel and Outlook, Visio 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. Ability to follow oral and written instructions, read, interpret and update engineering manuals/drawings relevant to the trade or the assigned task
- Self-starter who is able to work both independently without direct supervision or in a team environment
- Knowledge of FDA regulations and local building codes
- Technical Knowledge
- Problem Solving / Troubleshooting
- Team Player
- Customer Focus
- Action Oriented / Tenacity
Education & Experience:
- BS degree in mechanical, electrical engineering or similar engineering field
- Minimum 3-5 years of facilities maintenance/operations experience at an industrial or commercial site or related experience and/or equivalent combination of education and experience
- 2-5 years of GMP facility experience preferred but not required
Physical / Mental Demands:
- Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 50lbs
- Ability to sit, stand, walk and move within workspace for extended periods
- Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping, pushing and pulling
- Ability to climb ladders and work in elevated areas.
- Primarily office environment
- Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
- Ability to work safely in an environment with exposure to high temperature / pressure steam, and other fluids, compressed gasses, odors, various noise levels, moving parts, vibration, wet/slippery areas and high voltage energy supplies
- Environment may include working at heights, in cold temperatures, and/or constricted spaces
- Ability to work safely when working alone, or working with others.