Equipment Sr. Engineer (Pharmaceutical)

Technical Operations Rochester, Michigan


Description

The Equipment Sr. Engineer leads projects to develop engineering solutions to operational issues or new processes; implements system improvement or capital projects.  Establishes engineering project objectives and technical criteria for evaluating project results and activities of project team. Develops processes that lead to shortened cycle time; makes impact decisions.

 

Develops, plans, coordinates and directs engineering aspects of projects of major scope and importance; defines roles and accountabilities to avoid duplicate functions; manages external engineering services effectively; recommends resources required to carry out projects.

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.

Assigned U.S. based manufacturing site.

 

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

Accountability

Responsibilities

% of Time

Manufacturing Process Improvement

 

§  Develops process capability in support of production volume, while maintaining and improving quality standards.

§  Makes recommendations and takes proactive action to improve plant operations.

§  Designs systems for use in all phases of the manufacturing/packaging process.

§  Routinely has direct contact and manages outside consultants and technical counterparts from key vendors.

§  Creates new processes and manufacturing systems.

§  Supports maintenance and operations staff in the reviewing the operation of plant equipment and systems to minimize unplanned downtime, anticipate solve problems in a timely manner, and to identify opportunities for improvement.

§  Works with equipment designers and manufacturing/packaging teams to develop a cost-effective and working production process.

§  Plans and implements plant improvements and expansions.

50%

Project Management

§  Manages capital projects or process improvement initiatives, as required, to deliver within schedule and budget.  Scopes and carries out projects that improve efficiency and/or reduce operating costs.

§  Develops project schedules and budgets as required.

§  Coordinates activities with manufacturing, packaging, logistics, research and development, technical services and IT Departments.

§  Communicates regularly with all engineers, both individually and as a group, to ensure effective two-way communication concerning operational improvements and projects.

§  Manages outside consultants, contractors/vendors brought in to support design and/or project implementation.

30%

Commissioning / Qualification / Validation / Verification

§  Prepares, reviews, and executes commissioning/qualification/validation/ verification protocol documentation, as required, to support the implementation of manufacturing equipment/systems.

§  Prepares additional project lifecycle support documentation (e.g. Basis of Design, Process Workflow diagrams, Validation Test Plans, User and Functional Requirements Specifications, Design Specifications, and Requirements Trace Matrix as required).

20%

Total

100%

 

Qualifications

Education & Experience

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

§  Bachelor of Science degree in Chemical, Mechanical, or Electrical Engineering or related studies required with 10+ years’ progressive technical experience OR

§  MS with 8+ years’ experience as noted above.

§  Previous experience in cGMP manufacturing environment.

§  Pharmaceutical industry experience a plus.

§  Experienced with 2D and 3D design software (e.g. AutoCAD, SolidWorks).

§  Six Sigma certification a plus.


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.

§  Expert knowledge of cGMP and FDA regulations.

§  General understanding of Lean Manufacturing and Six Sigma principles.

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.

§  Expertise with Microsoft software (e.g. Word, Excel, Project, PowerPoint, Outlook, Visio).

§  Must have the ability to work effectively with a computerized maintenance management system and instruct others on its operation.

§  Able to establish and maintain cooperative working relationship with individuals contacted in the course of work.

§  Able to understand and follow oral and written instructions.

§  Able to communicate clearly and concisely, both oral and writing.

§  Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.

§  Planning/Organizing - 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.

§  Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.

§  Judgment - 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.

§  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.

§  Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

§  Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.

§  Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.

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.

§  Occasionally be required to climb or balance.

§  Occasionally be required to lift and/or move up to 50 pounds.

§  Occasionally exposed to outside weather conditions and risk of electrical shock.

§  May be exposed to high noise environments.

§  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

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.