Senior Engineer

Production Support Stratford, Connecticut


Description

Job Summary - a concise overview of the job

 

The Senior Engineer evaluates existing processes and manufacturing/packaging systems to reduce cost, improve sustainability and develop best practices within the production process. The engineer implements system improvements and capital projects; establishes engineering project goals and objectives and technical criteria; develops work and equipment processes that lead to shortened cycle time; supports the policies, goals and objectives of PAR Pharmaceutical. Leads and participates in planning and conducting work requiring judgement in the independent evaluation, selection and substantial adaptation and modification of standard techniques, procedures and criteria within engineering specialty. Performs work which has limited number of complex variables. Devises new approaches to problems encountered.

 

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.

 

 

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

Accountability

Responsibilities

% of Time

Process Improvement

§  Improve process capability and production volume while maintaining and improving quality standards

§  Prepare reports, analyzes data, and makes recommendations for improving plant operations and solving manufacturing/packaging-related problems

§  Develop and implement systems that optimize all phases of manufacturing/packaging process

§  Routinely has direct contact with outside consultants, technical counterparts from key vendors

§  Evaluate and improve on processes in manufacturing systems

§  Support 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

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

§  Assist with planning and implementing plant improvements and expansions

 

55%

Project Management

§  Manage capital projects or process improvement initiatives as required to deliver within schedule and budget. Scope and carry out projects that improve efficiency and/or reduce operating costs

§  Develop project schedules and budgets as required

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

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

§  Coordinate with and manage outside consultants, contractors/vendors brought in to support design and/or implement projects

25%

Commissioning / Qualification / Validation / Verification

§  Prepare, review, and execute commissioning/qualification/validation/ verification protocol documentation as required to support the implementation of manufacturing equipment/systems

§  Prepare 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

§  B.S. Engineering

§  Progressive technical experience (5 to 10 years) and demonstrated competence


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.

§  Proficient with Microsoft software (e.g. Word, Excel, Project, PowerPoint, Outlook, Visio) Must have expertise and proficiency with basic office computer software (i.e. word processing, email and spreadsheets)

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

§  Thorough knowledge of cGMP and FDA regulations

§  General understanding of Lean Manufacturing and Six Sigma principles

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

§  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.

§  Customer Service - 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.

§  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.

§  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.

§  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.

§  Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

§  Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.

§  Communication – communicates clearly (verbal and written); conveys issues in a timely manner

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.