Maintenance Planner & Reliability Engineer

• Must demonstrate a collaborative work style, with a strong ability to build relationships, gain credibility and partner with internal customers and co-workers. Strong organizational, communication and project management skills.
• Ability to perform a variety of duties often changing from one task to another of a different nature under the stress of frequent interruptions and/or distractions .
• Innovative skills in organizing materials, information, people in a systematic way to optimize efficiently and minimize duplication of efforts
• Partner with Supply Chain/Site Leadership in aligning resource needs with operational priorities.

Calm and structured thinking approach tracks parts to the point of delivery to the location and places newly arrived parts in defined stock location within the facility. Initiates documentation for changes in spare parts if applicable

• Must demonstrate a collaborative work style, with a strong ability to build relationships, gain credibility and partner with internal customers and co-workers. Strong organizational, communication and project management skills.
• Ability to perform a variety of duties often changing from one task to another of a different nature under the stress of frequent interruptions and/or distractions .
• Innovative skills in organizing materials, information, people in a systematic way to optimize efficiently and minimize duplication of efforts
• Partner with Supply Chain/Site Leadership in aligning resource needs with operational priorities.

Coordinates all parties involved in the planning, and execution process by assigning tasks, escorting and providing guidance for specific functions.

Implement and enforce work and safety rules, policies, and procedures

Solicit quotes from vendors/contractors when necessary for different projects and schedule maintenance with original equipment manufacturers (OEM) or third-parties using BMRAM).

Perform failure modes and effects analysis on machinery. Perform analyses of assets including utilization, overall equipment effectiveness, remaining useful life, and other parameters to define condition, reliability, and costs.

Immediately communicates any gaps within either PM’s event or spare parts inventory control to the engineering management.

Supports maintenance operational needs in troubleshooting equipment or systems.

Ensures work performed by outside service providers is timely and at a reduced cost.

Requires routinely working independent or with area supervision for access to perform task within the facility.

Plans Facility Shutdowns ensuring alignment of outside vendors and spare parts.

Tracks and maintains personnel cGMP training requirements within Master control to ensure compliance at all times.

Covers area of responsible for maintenance supervisors during vacation and sick time.

Maintenance documentation shall be in compliance with site procedures and in keeping with cGMP and ISPE guidelines.

Execution of the work shall be in compliance with site standards and procedures. Strict cost control and adherence to the procurement policies.

Ensure all maintenance tasks follow site quality and engineering procedures where applicable.

Maintain close communication with all maintenance stakeholders by opportunely issuing reports, meeting minutes and action plans.

Maintenance documentation shall be in compliance with site procedures and in keeping with cGMP and ISPE guidelines.

Execution of the work shall be in compliance with site standards and procedures. Strict cost control and adherence to the procurement policies.

Ensure all maintenance tasks follow site quality and engineering procedures where applicable.

Maintain close communication with all maintenance stakeholders by opportunely issuing reports, meeting minutes and action plans.

Education

Bachelor Degree in Electrical or Mechanical Engineering or Chemical engineer

Experience

Preferably combination of 10 years of technical experience in a pharmaceutical manufacturing facility.

Knowledge and Skills

• Proficient and functional speech and written fluency with English language.
• Knowledge and skill in maintenance of assembly, set-up, dis-assembly, cleaning, troubleshooting, maintenance, and repairs on pharmaceutical facility.
• Oversees the day-to-day operations of the facilities department.
• Evaluates systems and/or facilities to determine maintenance or repairs that need to be performed.
• Skilled in reading and interpreting drawings and specifications.
• Ensures correct, accurate and timely documentation of work performed as per FDA and site requirements.
• Familiar with CMMS software and SAP.
• Basic knowledge of Pharma document for SOP, change control, Incident & CAPA.
• Periodically check the work progress of each project; provide immediate assistance and instruction as needed.
• Knowledge of estimating, budgeting, and scheduling practices.
• Organizes and oversees the schedules and work of staff and contractors.
• Basic knowledge on Building management system operation.
• Performs other related duties as assigned.
• Experience implementing and evaluating contracted work of outside maintenance service providers, suppliers and maintaining successful partnerships.
• Position requires an understanding and experience with BMRAM modules specifically PM generation, and modification and the development of spare part inventory control.
• Practical, relevant and significant related experience in pharmaceutical industry of various dosage manufacturing processes and equipment desired.
• Reliability Engineering Knowledge (Certification Preferred)
• Able to work well in a team-oriented environment; critical thinking and problem solving, results oriented, decision making, team building, able and willing to support peers.
• Able to organize, prioritize, and successfully repair, calibrate instruments and complete multiple projects, tasks, and issues in a timely manner.
• Functions independently in periods of supervision’s absence.
• Familiarity with pharmaceutical developing PM’s and spare part control for manufacturing equipment and facility equipment.
• Uses methodic analytical thinking and problem solving.

Leadership / Managerial Attributes

Minimal supervision with considerable latitude for independent judgment. Completes difficult assignments without assistance. May mentor less-experienced team members and assist team lead.