What are the responsibilities and job description for the Supervisor, Maintenance position at Piramal Group?
Business: Pharma Solutions
Department: Facilities, Maintenance & Engineering
Location: Lexington
Job Overview
The Maintenance Supervisor oversees a team of technicians, working to ensure the preventive and corrective maintenance of plant mechanical systems in a cGMP manufacturing environment.
Reporting Structure
Direct reports to Engineering Manager
Roles & responsibilities
- Manage a team of multi-disciplinary maintenance and calibration technicians, consultants, contractors, or others as assigned in meeting the team, site and corporate objectives.
- Provide performance management including career development, coaching & mentoring, and adhering to the PPS timelines and milestones for performance reviews and goal setting for all direct reports.
- Coordinate the maintenance of all mechanical systems.
- Coordinate the calibration and qualification of all instrumentation and related equipment.
- Ensure schedule adherence and compliance of PM and CAL events
- Ensure that equipment monitoring and proper documentation is performed.
- Audit cGMP documentation of work performed.
- Participates in cross functional teams to meet deadlines and achieve project objectives
- Work in a collaborative team environment and interact with other business units.
- Maintain spare parts inventories
- Interact and provide direction to direct reports and service providers/vendors relevant to area of responsibility
- Support any function of the other departments as necessary (e.g. Engineering and Validations)
- Ensure that work is performed within established safety guidelines.
- Ensure that clean and orderly work areas are maintained.
- Ability to write, revise and review relevant protocols and procedures.
- Supports Operations including troubleshooting, emergency response, and normal coverage of a 24/7 manufacturing operation.
- Reduces downtime in accordance with applicable company and regulatory guidelines.
- Develops, tracks and, improves key metrics (KPIs) around planning and scheduling (unplanned downtime, OEE, etc).
- Complete investigations and action items for equipment or calibration failure events
- Supports FEQ team and leadership on site initiatives, projects, day-to-day support, data gathering, etc.
- Develops/reviews and approves design documents, drawings, project plans, change controls, SOPs, PMs, cals, work orders, validation protocols and final reports and ensures compliance with cGMPs and current regulatory requirements. Resolves all deviations/discrepancies encountered during project execution.
- Reviews change requests for impact to equipment or process and supports QA compliance activities such as Product Quality Review.
- Other duties as assigned.
Education Requirements:
- B.A. or B.S. in a technical field or equivalent work experience
Experience
- 5 to 10 years of Maintenance/Instrumentation Supervision experience in a regulated industry, preferable in a pharmaceutical environment is required.
Competencies
- Ability to interpret engineering drawings
- Use applicable software such as MS Office, MS Project and Work Order software
- Ability to troubleshoot equipment problems using a variety of tools and diagnostic instrumentation.
- Working knowledge of Pharmaceutical processing equipment — Steam Sterilizers, Depyrogenation Ovens, Lyophilizers, Water Systems, VHP Generators, Lab Equipment, Precision Scales, HEPA Air Handlers, Isolators and Water Treatment Systems.
- Familiarity with automated control systems and PLC interfaces
Department: Facilities, Maintenance & Engineering
Location: Lexington
Job Overview
The Maintenance Supervisor oversees a team of technicians, working to ensure the preventive and corrective maintenance of plant mechanical systems in a cGMP manufacturing environment.
Reporting Structure
Direct reports to Engineering Manager
Roles & responsibilities
- Manage a team of multi-disciplinary maintenance and calibration technicians, consultants, contractors, or others as assigned in meeting the team, site and corporate objectives.
- Provide performance management including career development, coaching & mentoring, and adhering to the PPS timelines and milestones for performance reviews and goal setting for all direct reports.
- Coordinate the maintenance of all mechanical systems.
- Coordinate the calibration and qualification of all instrumentation and related equipment.
- Ensure schedule adherence and compliance of PM and CAL events
- Ensure that equipment monitoring and proper documentation is performed.
- Audit cGMP documentation of work performed.
- Participates in cross functional teams to meet deadlines and achieve project objectives
- Work in a collaborative team environment and interact with other business units.
- Maintain spare parts inventories
- Interact and provide direction to direct reports and service providers/vendors relevant to area of responsibility
- Support any function of the other departments as necessary (e.g. Engineering and Validations)
- Ensure that work is performed within established safety guidelines.
- Ensure that clean and orderly work areas are maintained.
- Ability to write, revise and review relevant protocols and procedures.
- Supports Operations including troubleshooting, emergency response, and normal coverage of a 24/7 manufacturing operation.
- Reduces downtime in accordance with applicable company and regulatory guidelines.
- Develops, tracks and, improves key metrics (KPIs) around planning and scheduling (unplanned downtime, OEE, etc).
- Complete investigations and action items for equipment or calibration failure events
- Supports FEQ team and leadership on site initiatives, projects, day-to-day support, data gathering, etc.
- Develops/reviews and approves design documents, drawings, project plans, change controls, SOPs, PMs, cals, work orders, validation protocols and final reports and ensures compliance with cGMPs and current regulatory requirements. Resolves all deviations/discrepancies encountered during project execution.
- Reviews change requests for impact to equipment or process and supports QA compliance activities such as Product Quality Review.
- Other duties as assigned.
Education Requirements:
- B.A. or B.S. in a technical field or equivalent work experience
Experience
- 5 to 10 years of Maintenance/Instrumentation Supervision experience in a regulated industry, preferable in a pharmaceutical environment is required.
Competencies
- Ability to interpret engineering drawings
- Use applicable software such as MS Office, MS Project and Work Order software
- Ability to troubleshoot equipment problems using a variety of tools and diagnostic instrumentation.
- Working knowledge of Pharmaceutical processing equipment — Steam Sterilizers, Depyrogenation Ovens, Lyophilizers, Water Systems, VHP Generators, Lab Equipment, Precision Scales, HEPA Air Handlers, Isolators and Water Treatment Systems.
- Familiarity with automated control systems and PLC interfaces
