Operations - Senior Manager, Facilities - TechDigital
Libertyville, IL
About the Job
Position is 100% onsite
The Senior Manager, Facilities directs and oversees the outsourced and self-performed facilities and maintenance operations for GMP facilities and equipment at the Libertyville site. Major areas of responsibility include maintenance, preventative maintenance, facilities maintenance and building automation systems.
The person this role, will be responsible for the generation, adherence to and maintenance of overall site maintenance procedures. This individual will be responsible for the hiring of internal and external personnel to support the completion of maintenance and metrology activities to support both large and small capital projects, as well as the completion of routine maintenance activities to support departmental goals. The person will be responsible for representing Client in any internal or external regulatory audits and will ensure compliance of departmental activities with cGMP as well as with internal policies and procedures and regulatory requirements. The individual works collaboratively with their immediate supervisors, team members and internal and external customers to achieve team goals and uses informal leadership opportunities and effective communication to influence team direction and continue to build trust and value. The person must be available 24/7 for critical site needs.
Responsibilities include, but are not limited to, the following:
Maintain GMP Maintenance and Metrology Program and Procedures
Lead team members in the development and approval of all site GMP maintenance and metrology programs and procedures.
Ensure that all aspects of responsible programs are maintained in a state of compliance with respect to corporate and regulatory standards.
Ensure site adherence to responsible programs and procedures.
Work with project team to develop and implement CMMS system to support GMP areas.
Management Responsibilities
Interview and hire internal and external personnel to fill necessary roles.
Provide direction to internal and external team members.
Manage the workload of team members.
Delegate, develop and motivate team members.
Set departmental and individual goals.
Deliver personnel performance reviews.
Ensure team members are appropriately trained for duties being performed.
Prepare departmental operational expense and capital budgets. Justify and work within approved headcount.
Maintain necessary KPI's to monitor and ensure proper performance of team.
Promote and ensure the safety of all team members and adherence to site EHS procedures and guidelines.
Assist with preparation of the department expense budget and tracking
Maintenance, Metrology and Facility Activities
Manages the following activities performed by the department:
Ensure all work performed complies with site policies and procedures.
Plan and identify all personnel necessary to complete routine preventative maintenance, normal priority work order and emergency work order activities in accordance with project schedules, manufacturing schedules and budgets.
Plan and identify all personnel necessary to complete routine calibration, normal priority work order and emergency work order activities in accordance with project schedules, manufacturing schedules and budgets.
Responsible for the review and approval of all maintenance and calibration plans necessary to qualify new equipment and facilities.
Maintain equipment and facilities system in compliance with cGMP as well as with policies, guidelines and procedures.
Maintain, upload new data into and manage site CMMS system Maximo.
Responsible for purchasing and maintaining the inventory for facility and equipment spare parts
Responsible for facilities maintenance of GMP areas
Provide support for site critical changes, deviations and investigations ensuring continued compliance.
Review, evaluate, sign off or delegate responsibility for the following documentation Standard Operating Procedures; Capital Appropriation Requests; Change control requests, purchase requisitions, work orders, etc.
Performs other tasks as assigned.
Building Automation System (validated (BEMS) and non-validated (Client)) Responsibilities
Ensure new work components comply with site policies and procedures.
Maintain systems in compliance with cGMP as well as with policies, guidelines and procedures.
Plan and identify all personnel necessary to maintain both validated and non-validated building automation system.
Review, evaluate, sign off or delegate responsibility for the following documentation Standard Operating Procedures; Capital Appropriation Requests; Change control requests, purchase requisitions, work orders, etc.
Ensure projects that add or modify components of these systems have appropriate oversight and personnel to complete project goals.
Regulatory Responsibilities
Represent department responsibilities in both internal and regulatory audits.
Act as SME or appoint appropriate SME's as necessary.
REQUIRED COMPETENCIES:
Knowledge, Skills, and Abilities:
Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, change control and good documentation practices.
Advanced knowledge of pharmaceutical facilities, manufacturing and laboratory systems.
Advanced knowledge of maintenance shop tools.
Advanced knowledge or process equipment, and plant utility systems including high pressure steam, heating hot water, plumbing, electric HVAC and clean utilities.
Advanced knowledge of automation systems including BEMS, Client and PLCs.
Advanced knowledge of CMMS systems used in a GMP environment such as BM RAM or Maximo.
Demonstrated experience and ability to deal appropriately with regulatory agencies.
Ability to develop, delegate and motivate others including direct and indirect reports.
Strong financial acumen.
Strong written and verbal communication skills.
Excellent interpersonal skills with experience dealing with a diverse workforce.
Strong multitasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
Strong presentation development and delivery skills.
Education and Experience:
BS degree or equivalent experience desired
Minimum ten years of experience in operations, maintenance and service management of industrial buildings, research buildings, and systems, office systems and utility plants.
7 years relevant work experience in the pharmaceutical industry desired.
5 years leading and managing direct reports
Will be driving site van and manning forklifts
The Senior Manager, Facilities directs and oversees the outsourced and self-performed facilities and maintenance operations for GMP facilities and equipment at the Libertyville site. Major areas of responsibility include maintenance, preventative maintenance, facilities maintenance and building automation systems.
The person this role, will be responsible for the generation, adherence to and maintenance of overall site maintenance procedures. This individual will be responsible for the hiring of internal and external personnel to support the completion of maintenance and metrology activities to support both large and small capital projects, as well as the completion of routine maintenance activities to support departmental goals. The person will be responsible for representing Client in any internal or external regulatory audits and will ensure compliance of departmental activities with cGMP as well as with internal policies and procedures and regulatory requirements. The individual works collaboratively with their immediate supervisors, team members and internal and external customers to achieve team goals and uses informal leadership opportunities and effective communication to influence team direction and continue to build trust and value. The person must be available 24/7 for critical site needs.
Responsibilities include, but are not limited to, the following:
Maintain GMP Maintenance and Metrology Program and Procedures
Lead team members in the development and approval of all site GMP maintenance and metrology programs and procedures.
Ensure that all aspects of responsible programs are maintained in a state of compliance with respect to corporate and regulatory standards.
Ensure site adherence to responsible programs and procedures.
Work with project team to develop and implement CMMS system to support GMP areas.
Management Responsibilities
Interview and hire internal and external personnel to fill necessary roles.
Provide direction to internal and external team members.
Manage the workload of team members.
Delegate, develop and motivate team members.
Set departmental and individual goals.
Deliver personnel performance reviews.
Ensure team members are appropriately trained for duties being performed.
Prepare departmental operational expense and capital budgets. Justify and work within approved headcount.
Maintain necessary KPI's to monitor and ensure proper performance of team.
Promote and ensure the safety of all team members and adherence to site EHS procedures and guidelines.
Assist with preparation of the department expense budget and tracking
Maintenance, Metrology and Facility Activities
Manages the following activities performed by the department:
Ensure all work performed complies with site policies and procedures.
Plan and identify all personnel necessary to complete routine preventative maintenance, normal priority work order and emergency work order activities in accordance with project schedules, manufacturing schedules and budgets.
Plan and identify all personnel necessary to complete routine calibration, normal priority work order and emergency work order activities in accordance with project schedules, manufacturing schedules and budgets.
Responsible for the review and approval of all maintenance and calibration plans necessary to qualify new equipment and facilities.
Maintain equipment and facilities system in compliance with cGMP as well as with policies, guidelines and procedures.
Maintain, upload new data into and manage site CMMS system Maximo.
Responsible for purchasing and maintaining the inventory for facility and equipment spare parts
Responsible for facilities maintenance of GMP areas
Provide support for site critical changes, deviations and investigations ensuring continued compliance.
Review, evaluate, sign off or delegate responsibility for the following documentation Standard Operating Procedures; Capital Appropriation Requests; Change control requests, purchase requisitions, work orders, etc.
Performs other tasks as assigned.
Building Automation System (validated (BEMS) and non-validated (Client)) Responsibilities
Ensure new work components comply with site policies and procedures.
Maintain systems in compliance with cGMP as well as with policies, guidelines and procedures.
Plan and identify all personnel necessary to maintain both validated and non-validated building automation system.
Review, evaluate, sign off or delegate responsibility for the following documentation Standard Operating Procedures; Capital Appropriation Requests; Change control requests, purchase requisitions, work orders, etc.
Ensure projects that add or modify components of these systems have appropriate oversight and personnel to complete project goals.
Regulatory Responsibilities
Represent department responsibilities in both internal and regulatory audits.
Act as SME or appoint appropriate SME's as necessary.
REQUIRED COMPETENCIES:
Knowledge, Skills, and Abilities:
Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, change control and good documentation practices.
Advanced knowledge of pharmaceutical facilities, manufacturing and laboratory systems.
Advanced knowledge of maintenance shop tools.
Advanced knowledge or process equipment, and plant utility systems including high pressure steam, heating hot water, plumbing, electric HVAC and clean utilities.
Advanced knowledge of automation systems including BEMS, Client and PLCs.
Advanced knowledge of CMMS systems used in a GMP environment such as BM RAM or Maximo.
Demonstrated experience and ability to deal appropriately with regulatory agencies.
Ability to develop, delegate and motivate others including direct and indirect reports.
Strong financial acumen.
Strong written and verbal communication skills.
Excellent interpersonal skills with experience dealing with a diverse workforce.
Strong multitasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
Strong presentation development and delivery skills.
Education and Experience:
BS degree or equivalent experience desired
Minimum ten years of experience in operations, maintenance and service management of industrial buildings, research buildings, and systems, office systems and utility plants.
7 years relevant work experience in the pharmaceutical industry desired.
5 years leading and managing direct reports
Will be driving site van and manning forklifts
Source : TechDigital
