Process Engineer II

Production Support Rochester, Michigan


Description

Job Summary - a concise overview of the job

The Process Engineer II, under general direction, performs various duties related to optimization and analysis of production processes, new products and processes, and technology transfers. Provides support for troubleshooting and improvements to existing products and processes.

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.

§  Process engineering duties within a single location.

§  Make decisions within guidelines and policies. 

§  Perform duties using knowledge and work experience. Requires only general direction.  Work is reviewed for adequacy in meeting objectives.  Work within a time horizon of monthly/quarterly objectives

§  Work is measured by output meeting and achieving pre-defined quarterly/semi-annual targets.

 

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

Accountability

Responsibilities

% of Time

Validation Protocols

§  Prepare and execute engineering study protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols and complete interim and / or final summary reports for marketed and new products.

§  Coordinate with Facilities, Engineering, Manufacturing, Packaging, Product Development, Analytical Services, RA, and QA to initiate manufacturing and packaging experimental / feasibility study / validation projects for marketed and new products.

25%

Technical Transfer

§  Perform on-site and site-change technical transfer, scale-up or scale-down factor evaluation, manufacturing / packaging process and equipment troubleshooting, and SOP preparation and review.

20%

Formulation Development

§  Conduct formulation development and evaluation for marketed and new products.

20%

Troubleshooting

§  Troubleshoot the setup and operation of manufacturing/packaging equipment and the process of new R&D projects.

§  Conduct investigations on deviations.

§  Evaluate and troubleshoot mid to high level manufacturing / packaging equipment and process issues.

§  Work on problems of increasing complexity where analysis of situation or data requires review of identifiable factors.  Recommend solutions to technical issues.

20%

Training

§  Conduct training to related department personnel on all technical and project-related documents, such as batch records, protocols, and SOP etc.

15%

Teamwork

·       Frequently interact with team members, supervisors, outside customers/vendors, & other teams/departments. Interaction normally requires the ability to gain cooperation of other departments, conducting presentations of technical information concerning specific projects/schedules, etc.

-

Total

100%

 

Qualifications

Education & Experience

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

§  BS degree in Engineering or Chemical Engineering preferred with 5+ years’ related experience OR

§  MS with 3+ years’ experience as noted above OR

§  PhD with 0-1 year of experience as noted above.



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.

§  Knowledgeable of Current Good Manufacturing Practices (cGMP), FDA, OSHA, EPA, DEA; other regulatory requirements.

§  Complete understanding of Pharmaceuticals manufacturing principles, practices and applications.

§  Working knowledge of Analytical test methodology (BU, Assay, CU and dissolution profile, etc.).

§  Understanding of concepts of equipment qualification/calibration.

§  Understanding of computer validation concepts.

§  Intermediate statistical computations (Cp, Cpk, regression analysis, etc.); use of statistical software.

§  Personal computer operations and MS applications (Word, Access, Excel, PowerPoint, MS Project).

§  Has general working knowledge of principles and concepts of other disciplines within own function.

§  Is recognized by colleagues as a technical expert and provides technical advice and counsel on complex problems in areas of expertise.

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.

§  Is able to write clearly and succinctly for the technical community and can construct logical arguments well.

§  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.

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

§  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.

§  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.

§  Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.

§  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.

§  Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.

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.

§  Employee is occasionally required to climb or balance; must occasionally lift and/or move up to 50 pounds.

§  Employee is frequently exposed to moving mechanical parts, and occasionally exposed to outside weather conditions and risk of electrical shock.

§  The noise level in the work environment is usually moderate.

 

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.