Maintenance Automation Manager

Facilities Rochester, Michigan


Description

Job Description

 

Job Title

Maintenance Automation Manager

Company

Par Pharmaceutical

Function

Operations & Manufacturing

Location(s)

Rochester, MI

Department

Maintenance Engineering

Direct Reports (list)

N/A

Reports to (title)

Dir, Maintenance Engineering

Date Submitted

10/8/2020

 

Job Summary - a concise overview of the job

The Maintenance Automation Manager is responsible for the oversight of Process Control and Building Automation/Controls systems.  The incumbent will provide direction and vision for process and building automation/controls and manage activities for modifications to existing automation/controls systems to improve productivity, efficiency, compliance and safety with cGMP quality standards.  The Manager is also responsible for the recommendation of continuous data integrity improvements along with new systems, design and implementation for cGMP manufacturing systems and the preventive maintenance (PM) program for Process/Building Automation/Controls systems. He/she will liaise as SME for automation/controls anomalies that affect manufacturing/products.     

 

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Responsible for the sterile fill and packaging operations for current products in addition to the COVID-19 vaccine fill and new automated packaging lines.

 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Operational Readiness

  • Manages and directs automation/controls resources.
  • Provides technical engineering/project leadership.
  • Prepares scopes and project documentation for development and implementation of new and retrofit automation/controls systems.
  • Reviews new project/product initiatives with regard to automation/controls.
  • Develops and manages automation specifications/standards.
  • Directs and collaborates with automation/engineering investigations when product-related equipment and system abnormalities occur.
  • Actively collaborates in equipment troubleshooting, preventive maintenance, calibration and repair for process and building automation/controls systems.
  • Actively participates in regulatory and contract customer audits involving equipment and facilities.
  • Coordinates maintenance and engineering activities with manufacturing and logistics managers to ensure maintenance of equipment and facilities necessary to support product manufacturing, packaging and testing, as needed.
  • Provides regular reports to communicate departmental activities, project status and events that have an impact on manufacturing operations.

50%

Strategy

  • Develops and maintains Process and Building Automation master plans and design standards, ensuring continually improved data integrity measures.
  • Promotes automation and technology advantages within the organization.
  • Provides high-level direction for process and building automation/controls.
  • Manages strategy goals and objectives where assigned.
  • Collaborates with site managers for a cohesive automation/controls process that aligns with operations.
  • Ensures that Process & Building Automation systems and equipment are maintained in accordance with all cGMP, OSHA, governmental and corporate standards.

30%

Development & Training

  • Keeps abreast of current industry best practices and strategies in Pharmaceutical automation/controls.
  • Develops and trains maintenance/site personnel in automation/controls best practices.
  • Develops and manages appropriate automation/controls SOPs and system documentation programs.

20%

Total

100%

 

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

  • Bachelor of Science degree in an engineering discipline or equivalent education/experience in a government regulated industry in the engineering and/or maintenance fields is required.
  • Bachelor of Science degree in Mechanical, Chemical, Computer Science, Bio Medical or Electrical Engineering is desired.
  • 8 years of experience in the engineering and/or maintenance field is required.
  • 5 years of pharmaceutical experience in the engineering and/or maintenance field including a minimum of 3 years of project management experience is desired.

Knowledge

Proficiency in a body of information required for the job   

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

  • Keeps abreast of current industry best practices and strategies in Pharmaceutical automation/controls.
  • Demonstrated knowledge of FDA, cGMP regulations and guidelines, especially 21CFR Parts 11, 210 and 211.
  • Demonstrated computer proficiency: Microsoft Suite and AutoCAD.
  • Knowledge of how equipment is used in pharmaceutical plant operations and the typical measurements which are critical to operation.

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.

  • Ability to engage trades people and effectively build relationships to drive performance.
  • Ability to work independently, efficiently, and effectively.
  • Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
  • Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
  • Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
  • Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
  • Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
  • Ability to handle multiple projects and assignments; Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
  • Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.
  • Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
  • Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
  • Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

  •  

 

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

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Endo Job Description Template - Revised April 2017