58 applicants

Company

Original Job Post

PCI Pharma Services · 3 days ago

Process Engineer

Philadelphia, PA

Full-time

Onsite

Mid Level

1+ years exp

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Responsibilities

Analyzes sales requests to determine equipment, tooling, or delivery systems needed.

Performs engineering review of all components for new jobs to include size, capability of equipment, and bar codes

Apply sound engineering principles to design new production lines and component layout, with a goal of designing a process capable of low defects (less than 1%), high uptime (greater than 95%), low waste (less than 1%), and throughput better than estimate.

Conduct and/or participates in customer meetings and attends occasional off-site meetings.

Interact with the sales department and customers to determine requirements for new products and orders.

Participate in internal review meetings to plan new jobs with plant operations, Maintenance, Quality, Purchasing and Process Engineering.

Prepare SOPs, line layouts, production line diagrams as needed.

Specify, order, and commission tooling as required for launch activities.

Specifies equipment needed, prepares RFQs, and obtains quotes from vendors

Write CER’s (Capital Equipment Requests) for new equipment which includes researching the justification for usage.

Negotiate and order equipment when approved.

Writes protocols for URS’ (User Requirement Specifications), FAT’s (Factory Acceptance Tests), & SAT’s (Site Acceptance Tests.

Determine OQ parameters to start validation.

Approves validation protocols and MPI’s.

Commissioning of equipment including all necessary change controls and training, including leading FAT & SAT activities.

Responsible for the administration, implementation, and project management of assigned projects, including using standardized methodology.

Research new trends and technologies in packaging; evaluates and tests new equipment and processes.

Coordination of outside design, integration, and equipment manufacturing services.

Work with staff on development of new equipment performance requirements.

Assist Validation with OQ and PQ of new packaging business.

Write and modify SOPs relating to the production area and assist in training of affected personnel.

Leads CAPA investigations and actions. Initiate investigation activity and troubleshoot problems in packaging; discovers causes of non-conformance, i.e., slow throughput, inadequate quality and/or unsafe design.

Writes and executes engineering protocols as needed.

Use DOE (Design of experiments) to control variables while testing.

Applies sound engineering principles to improve existing equipment, packaging design and processes by reducing waste, increasing throughput, reducing energy consumption, or eliminating human interaction through automation.

Facilitates cross-functional Lean Six Sigma process improvement teams using a DMAIC method.

Responsible for the administration, implementation, and project management of new business, including conformance with customer requirements and equipment / process performance criteria.

Measure and analyze performance metrics of the production area and spearhead initiatives to decrease variability and waste.

This position may require overtime and/or weekend work.

Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

Attendance to work is an essential function of this position.

Performs other duties as assigned by Manager/Supervisor.

Qualification

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College level mathematical skills computer skillsFull professional proficiencyProblem-solvingReasoningReport writingTime managementPresenting informationOriginal thinkingCreativityGoal setting

Required

Bachelor's Degree in mechanical, packaging engineering, or in a related field of study.

1-5 years related experience and/or training.

College Level Mathematical Skills

Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.

Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.

Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

High Standard of Report Writing