Senior Director of Engineering, Maintenance, and Facilities Job at PCI Pharma Services (Bedford, NH)

Job Description

Accountable for all aspects of Engineering, Instrumentation and Controls, Utilities, Facilities, and Maintenance in supporting pharmaceutical and medical device product manufacturing across the PCI Manchester and Bedford, NH campus. Provide leadership to ensure the highest level of quality and adherence to cGMPs across the site. This role is responsible for managing people, providing quality and technical direction, and actively participating in driving and developing strategies for continuous improvement within the department.

Job Responsibility

Accountable for all aspects of Engineering, Instrumentation and Controls, Utilities, Facilities, and Maintenance in supporting pharmaceutical and medical device product manufacturing across the PCI Manchester and Bedford, NH campus
Provide leadership to ensure the highest level of quality and adherence to cGMPs across the site
Responsible for managing people, providing quality and technical direction, and actively participating in driving and developing strategies for continuous improvement within the department
Manages and oversees all areas of process engineering, automation, calibration, facilities, operation of utilities including HVAC, buildings and ground maintenance, and maintenance of utilities and facilities supporting aseptic operations and non-aseptic medical device manufacturing activities across multiple plants
Responsible for management of CAPEX projects
Ensures all aspects engineering and facilities are adhering to cGMPS and PCI’s established SOPs
Ensures all projects are executed safely, on time, and within budget
Identifies, prepares and leads small CAPEX projects
Responsible for all aspects of Engineering, Instrumentation and Controls, Utilities, Facilities, and Maintenance programs
Determine appropriate equipment, line, tooling, costs and capacities for new projects or changes to existing projects
Instill a strong culture of Lean and Continuous Improvement through the use of the site maturity index
Oversees the departmental budget and headcount
Provides coaching, mentoring and development to each direct report
Provides leadership to ensure engineering and facilities support manufacturing operations
Directs general and specialized maintenance, small CAPEX projects, facility renovation, construction, and repair of grounds, buildings, equipment, utility systems
Ensures team compliance with all corporate policies and procedures
Provides direction to people managers in the areas of compliance, safety, deviations, corrective and preventive actions, investigations and complaints
Works closely with key functions such as Quality, Manufacturing, EH&S, Sales/Project Management, Global Engineering, and Global PMO
Analyzes existing processes/unit operations and determine modifications necessary to improve safety and streamline processes
Supports Continuous improvement activities tied to budget goals and helps lead key ES&G initiatives
Directs and supervises assigned personnel, including performance evaluations, scheduling, orientation and training
Maintains the professional competence, knowledge and skills necessary for the satisfactory performance of all assigned responsibilities
Provides leadership in analyzing and developing improvements in process efficiency, quality, safety and client relationships
Correctly implements industry best practices that will successfully withstand regulatory inspections
Responsible for administration of Computerized Maintenance Management System (CMMS) and maintenance planning
Part of the Site Leadership Team (SLT)

Requirements

Operational background in cGMP environment, preferably in aseptic manufacturing/engineering
Demonstrated skill in managing a diverse population of professional, technical, and hourly personnel as well as external resources
Experience in working with regulators during inspections/audits is highly desired
10-12 years of experience in the field of technical engineering support to biopharma/pharm and/or medical device facilities
8-10 years of experience in management of professional and technical staff with accountability for objectives and subsequent evaluation
5-8 years of experience with engineering and maintenance support to biopharma/pharm and/or medical device facilities
5 years of experience managing managers with accountability for objectives and subsequent evaluation
Experience with company financial systems and an understanding of accounting practices and financials a plus
Experience with direct exposure to Customers in a CDMO business is a plus
Bachelor's degree in engineering discipline required
Master's degree in engineering or business administration preferred
Demonstrate commitment to continuous improvement at all levels within the organization
Excellent organizational skills
Ability to prioritize multiple ongoing projects and activities to meet customer and company timelines
Excellent verbal and written communication skills
Ability to effectively manage multiple projects, teams and technical staff at all levels
Ability to assess and develop organizational talent which includes engaging employees and driving technical and personal development
Performance measurement and KPI Tracking and Reporting
Proficiency with MS Office suite is preferable
Possess advanced leadership competencies which support the rigidity of GMP operations against the competing demands of a CDMO environment
Leads by example to motivate and engage through clear communication, of vision and goals
Demonstrates resilience and takes on a proactive approach to change management to enable leaders to drive the change successfully

Nice to have

Experience in working with regulators during inspections/audits
Experience with company financial systems and an understanding of accounting practices and financials
Experience with direct exposure to Customers in a CDMO business
Master's degree in engineering or business administration

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