- Ensures all aspects engineering and facilities are adhering to cGMPS and PCI's established SOPs. Makes the necessary recommendations and changes to improve process efficiencies.
- 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 the site maturity index
- Oversees the departmental budget and headcount
- Provides coaching, mentoring and development to each direct report both in execution of their group responsibilities and in their own development.
- Provides leadership to ensure engineering and facilities support manufacturing operations in a fashion that focuses on quality and adherence to the maintenance schedule in support of Operations
- Directs general and specialized maintenance, small CAPEX projects, facility renovation, construction, and repair of grounds, buildings, equipment, utility systems, at all manufacturing, warehousing and office facilities within the Leon facility.
- 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 to ensure internal and external clients' requirements are met.
- Analyzes existing processes/unit operations and determine modifications necessary to improve safety, as needed 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. Recommends employee hires, transfers, promotions, salary changes, discipline, terminations and similar actions, as appropriate.
- 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 (internal and external).
- Correctly implements industry best practices that will successfully withstand regulatory inspections by regulatory authorities.
- Responsible for administration of Computerized Maintenance Management System (CMMS) and maintenance planning.
- Part of the Site Leadership Team (SLT).
- Performs other duties as assigned.
- 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. Setting future leadership for success.
- Performance measurement and KPI Tracking and Reporting
- Proficiency with MS Office suite is preferable
- English is a must.
- 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.
- Master's degree in Engineering or Business Administration preferred.
- 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
- A frequent volume of work and deadlines may impose strain on a routine basis.
- Minimal physical effort is required.
- Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.
- Effective verbal and written communication with both internal and external contacts is critical to success
- Oversees a wide array of subordinate managers, supervisors, and technicians across multiple shifts and locations within the campus
- Set a clear vision and direction for the reporting functions, encouraging communication and a team-based approach
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Director Engineering, Maintenance - León, España - PCI Pharma Services
Descripción
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Accountable for all aspects of Engineering, Instrumentation and Controls, Utilities, Facilities, and Maintenance in supporting pharmaceutical and medical device product manufacturing at the PCI Pharma Services Leon site. 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. 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. Additionally responsible for management of small CAPEX projects.
Reports to Vice President, Global Engineering.
– <10% domestic and some international
Join us and be part of building the bridge between life changing therapies and patients.
