Overview

the Sr. Process Engineer is responsible for evaluating existing processes and configuring manufacturing equipment and systems to reduce cost, improve sustainability, and develop best practices within the production process by applying systems engineering principles and technology of chemistry, physics, and equipment engineering.

Responsibilities

· Design and specify cGMP process equipment, piping and controls related to the creation of products that improve process capability and production volume while maintaining and improving quality standards.

· Manage small-to-mid size projects related to process equipment and manufacturing.

· Assist in the design review, site acceptance and installation of equipment.

· Evaluate and improve manufacturing systems.

· Maintain reliable and safe manufacturing systems while improving production rates, efficiencies, yields, reducing overall operating costs and minimize/optimize system changeovers.

· Coordinate and perform filling & packaging engineering trials and then prepare reports and summarize the findings.

· Prepare necessary documentation to support engineering projects including project scopes, presentation of conceptual designs, capital requests, specifications, piping and instrumentation diagrams, process flow diagrams, schedules, requests for quotations, project expenditures, project procedure, correspondence, start-up procedures and cost estimates.

· Support QA and Validation departments by preparation of design documents and assisting in protocol generation and execution.

· Assist in investigations or process equipment, utility systems, and control anomalies as well as safety incidents.

· Implements connective/preventive actions for existing equipment and manufacturing processes.

· Prepare change control documentation.

· Write and modify procedures for the proper operation of new and/or existing equipment.

· Propose and implement operational efficiency improvements for packaging lines.

· Prepare labor-requirement estimates for new and existing packaging arrangements.

· Assess safety requirements and ensure that these are integrated into the process.

· Research and purchase new manufacturing technology and environmentally friendly practices into existing processes.

· Ensure projects are completed on time.

· Ensure financial budgets are followed.

· Assist with training of operations and maintenance personnel as needed.

· May supervise mechanical, electrical and automation contractors as well as Contract Engineers and Construction Contractors.

· Provide guidance and mentor Process Engineers within the Engineering Department.

· Troubleshoot filling and packaging equipment and provide solutions to prevent downtime.

Qualifications

B.S. degree in Chemical, Biochemical or Mechanical Engineering is required. A minimum of five (5) years of relevant experience in the pharmaceutical industry is preferred.