• Abacus Service Corporation
  • $93,100.00 -129,290.00/year*
  • Westwood , NJ
  • Engineering
  • Full-Time
  • 415 Old Tappan Rd

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Description/Comment: Responsible for providing technical support, co-ordination and expertise for new technology introductions, packaging automation, and other existing technologies to the Somerset site. This position will have direct responsibility for ensuring that GMP, Safety, and other regulatory considerations are clearly developed and implemented in the associated procedures, preventive maintenance records, engineering controls and maintenance processes. Will develop key process engineering/maintenance data sets, spare parts procurement/control, FMEA studies, and process and facilities control mechanisms to develop performance optimization.

Leads in providing innovative solution as they pertain to processing unit operations in the Somerset site focusing on process optimization, automation and efficiency.
Creates and monitor key equipment performance metrics such as equipment downtime and reject trends
Uses statistical thinking and methods to understand process variability and capability and drive process improvements.
Determines process capabilities and bottlenecks, implement improvements, and develop contingency plans for capacity/productivity increases.
Identifies failure modes of equipment and maintenance strategies to mitigate impact of failure.
Guides the specification and selection of manufacturing/utility equipment to support the process needs.
Responsible for the design and implementation of the process systems. Ensures this work meets cGMP (current Good Manufacturing Practices) expectations.
Works with operations, validation, process development and quality functions to provide support for the design, installation, start-up, validation and operation of facility and or process equipment.
Evaluates PMs and SOPs to ensure that they reflect current practices and they are executed optimally to meet performance expectations. Interfaces with Project Engineers and end users to maintain and control hardware and software of process unit operations.
Assignment of and management of process and facilities related Deviations, CAPAs, and Change Controls.
Responsible for working with the Original Equipment Manufacturers (OEM) to acquire expert knowledge for transfer internally and personal growth.
Leads the implementation of new equipment, policies and/or procedures.
Works on highly complex problems where analysis requires evaluation of factors of intangible variables. Exercises independent judgment in developing methods, techniques and evaluation criteria. Demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought.
Coordinates activities with Operations team to ensure proper prioritization.
Determines approaches to be utilized for assigned projects, then plans and executes work independently with minimal supervision. Takes a leading role in assuring the successful timely scale-up and transfer of formulations and processes from pilot plant to full-scale production, for either incoming or outgoing products related to new technology in Operations
Communicates effectively to all levels in all forms of communication.
Makes suggestions, recommendations, and contributions to process development and supports manufacturing activities for pharmaceutical products in a CGMP facility.
Serves as a technical liaison for internal or external customers regarding manufacturing operations on new or existing product development.
Recommends process and procedure changes designed to increase efficiency, safety, and/or quality.
Remains flexible with respect to maintenance priorities and ensures that site and overall engineering departmental business objectives are met.
Supports the long-term goals of Somerset Site Operations as defined by the Department Heads and General Manager
Stimulates new ideas and approaches and encourages team cooperation. Hours: 8:00am to 5:00pm Location: 113 14 Schoolhouse Road Somerset NJ 08873 United States Education: Business Unit DDS Job Qualifications BS or BA degree with concentrated studies in Engineering (Process, Mechanical, Chemical, Pharmaceutical) preferred with minimum 5+ years working with a cGMP manufacturing or pharmaceutical products facility
Alternatively, minimum 10+ years' practical experience working with a cGMP manufacturing or pharmaceutical products facility that provide a working knowledge base of properties, theories, and manufacturing and packaging processes associated with manufacture and packaging of pharmaceutical products and contract manufacturing.
Good Communication Skills: Written and verbal.
Basic knowledge of Lean Six Sigma and FDA cGMP's preferred
Experience in Pharmaceutical industry preferred
Experience applying Six Sigma and Lean techniques in a transactional environment
Proficient and Exceptional Skills in Microsoft Office Tools: Excel, Access, Word, PowerPoint and Visio required
Proficient in AutoCAD & SCADA systems
Proficient in use of Minitab statistical software
Demonstrated leadership skills
Superior interpersonal, verbal and written communication skills; able to communicate effectively and interact with personnel at all levels of technical ability and expertise
Excellent problem-solving skills
Excellent Influencing Skills: demonstrated ability to get results through others not under direct supervision
Superior customer service orientation with strong follow-up skills and
attention to detail
Able to work under deadlines and handle multiple and detail-oriented tasks in a fast paced environment
Must have well-developed human relations skills and be able to apply in advance, a combination of knowledge, imagination, judgment, and realistic appraisal in project evaluations.





Job Title: Process Engineer

Date: 29AUG2017

FLSA Status: Non-Exempt

II. Essential Functions:
This position is responsible for providing technical support, co-ordination and expertise for new technology introductions, packaging automation, and other existing technologies to the Somerset site. This position will have direct responsibility for ensuring that GMP, Safety, and other regulatory considerations are clearly developed and implemented in the associated procedures, preventive maintenance records, engineering controls and maintenance processes. This position will develop key process engineering/maintenance data sets, spare parts procurement/control, FMEA studies, and process and facilities control mechanisms to develop performance optimization. III. Specific Duties, Activities, and Responsibilities:
  • Leads in providing innovative solution as they pertain to processing unit operations in the Somerset site focusing on process optimization, automation and efficiency.
  • Creates and monitor key equipment performance metrics such as equipment downtime and reject trends
  • Uses statistical thinking and methods to understand process variability and capability and drive process improvements.
  • Determines process capabilities and bottlenecks, implement improvements, and develop contingency plans for capacity/productivity increases.
  • Identifies failure modes of equipment and maintenance strategies to mitigate impact of failure.
  • Guides the specification and selection of manufacturing/utility equipment to support the process needs.
  • Responsible for the design and implementation of the process systems. Ensures this work meets cGMP (current Good Manufacturing Practices) expectations.
  • Works with operations, validation, process development and quality functions to provide support for the design, installation, start-up, validation and operation of facility and or process equipment.
  • Evaluates PMs and SOPs to ensure that they reflect current practices and they are executed optimally to meet performance expectations.
  • Interfaces with Project Engineers and end users to maintain and control hardware and software of process unit operations.
  • Assignment of and management of process and facilities related Deviations, CAPAs, and Change Controls.
  • Responsible for working with the Original Equipment Manufacturers (OEM) to acquire expert knowledge for transfer internally and personal growth.
  • Leads the implementation of new equipment, policies and/or procedures.
  • Works on highly complex problems where analysis requires evaluation of factors of intangible variables. Exercises independent judgment in developing methods, techniques and evaluation criteria. Demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought.
  • Coordinates activities with Operations team to ensure proper prioritization.
  • Determines approaches to be utilized for assigned projects, then plans and executes work independently with minimal supervision. Takes a leading role in assuring the successful timely scale-up and transfer of formulations and processes from pilot plant to full-scale production, for either incoming or outgoing products related to new technology in Operations
  • Communicates effectively to all levels in all forms of communication.
  • Makes suggestions, recommendations, and contributions to process development and supports manufacturing activities for pharmaceutical products in a CGMP facility.
  • Serves as a technical liaison for internal or external customers regarding manufacturing operations on new or existing product development.
  • Recommends process and procedure changes designed to increase efficiency, safety, and/or quality.
  • Remains flexible with respect to maintenance priorities and ensures that site and overall engineering departmental business objectives are met.
  • Supports the long-term goals of Somerset Site Operations as defined by the Department Heads and General Manager
  • Stimulates new ideas and approaches and encourages team cooperation.
  • Leads specialized task force teams to mentor, coach, and teach throughout the facility.
  • Provides support to QA for manufacturing activities involving equipment, processes, calibration, and equipment qualification.
  • Interprets, evaluates, communicates, and properly documents the results of all work and makes recommendations for action.
  • Complies with Health, Safety and Environmental responsibilities.
  • Complies with Departmental and company policies.
  • Prepares reports and presentations on project progress as well as specifications, procedures, and SOPs
  • Keeps abreast of scientific literature which may have relevance to Catalent technologies.
  • Assumes other duties as required.
  • IV. Position Requirements:
    Supervises: N/A

    Education or Equivalent:
  • BS or BA degree with concentrated studies in Engineering (Process, Mechanical, Chemical, Pharmaceutical) preferred with minimum 5+ years working with a cGMP manufacturing or pharmaceutical products facility
  • Alternatively, minimum 10+ years' practical experience working with a cGMP manufacturing or pharmaceutical products facility that provide a working knowledge base of properties, theories, and manufacturing and packaging processes associated with manufacture and packaging of pharmaceutical products and contract manufacturing.
  • Good Communication Skills: Written and verbal.
  • Basic knowledge of Lean Six Sigma and FDA cGMP's preferred
  • Experience in Pharmaceutical industry preferred
  • Experience applying Six Sigma and Lean techniques in a transactional environment
  • Proficient and Exceptional Skills in Microsoft Office Tools: Excel, Access, Word, PowerPoint and Visio required
  • Proficient in AutoCAD & SCADA systems
  • Proficient in use of Minitab statistical software
  • Demonstrated leadership skills
  • Superior interpersonal, verbal and written communication skills; able to communicate effectively and interact with personnel at all levels of technical ability and expertise
  • Excellent problem-solving skills
  • Excellent Influencing Skills: demonstrated ability to get results through others not under direct supervision
  • Superior customer service orientation with strong follow-up skills and
  • attention to detail
  • Able to work under deadlines and handle multiple and detail-oriented tasks in a fast paced environment
  • Must have well-developed human relations skills and be able to apply in advance, a combination of knowledge, imagination, judgment, and realistic appraisal in project evaluations.



  • Knowledge/Skills Requirements:
  • Team Facilitation: Build a successful/cohesive team using development tools, resources, training, goals, performance measures and a flexible interpersonal style. Facilitate the completion of team goals.
  • Problem Solving: Identify present and potential troublesome situations and their causes. Investigate to a level that reveals total impact of the situation. Identify trends and patterns and develop measures to solve or prevent repeat occurrence.
  • Process Orientation: Ability to understand customer requirements, define/understand processes, and their effectiveness, efficiency and adaptability; ability to take a systematic view of activities from a broad perspective; analyze processes; establish
  • Change Facilitation: Encourage individuals to seek opportunities for different and innovative approaches to addressing problems and opportunities. Facilitate the implementation and acceptance of change within the workplace
  • Communication Skills: Convey and/or absorb information and ideas through a variety of media to individuals or groups in a manner that engages an audience and helps them understand and retain the message
  • Computer Knowledge: Understands and uses the basic office tools available on a personal computer. Can do basic word processing, spreadsheets, e-mails, presentations and web browsing.
  • Program and Project Management: Identify customers, deliverables, project scope, plan and resources; remove obstacles; meet quality, cost and timeliness goals; and make decisions.
  • Financial Skills: Utilize cost analysis methods and procedures to determine resource allocations and evaluate alternatives in shop and office areas; using established principles and practices, gather data, interpret information, and explain fluctuations.

  • Associated topics: autocad, automotive, bsme, mechanical, mechanic, msme, powertrain, solidworks, turbomachinery, vehicle

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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