Mechanical Engineer

4 weeks ago

Philadelphia, United States PROMAN Staffing USA Full time

PROMAN Staffing has partnered with global pharma packaging solutions provider to source and hire a PACKAGING MECHANICAL ENGINEER to join their Engineering team department onsite at their Philadelphia, PA facility.



This is a DIRECT HIRE opportunity



The Packaging Mechanical Engineer will support and collaborate with the client’s Manufacturing Operations team in maintaining equipment and executing project plans directly related to packaging. This includes new client product introductions, new market launches, supplier changes, manufacturing line support and package development. The Engineer will establish packaging systems that meet the needs of our client’s customers with optimal process and cost effectiveness. The Packaging Mechanical Engineer is expected to manage projects and provide expert leadership concerning packaging and packaging systems, and collaborate with internal teams such as Quality, Technical Services, and Manufacturing, as well as with the external customers in reviewing projects, providing input on packaging proposals, and recommending creative packaging solutions.


PACKAGING MECHANICAL ENGINEER RESPONSIBILITIES:

· Ensures that machines are properly maintained and PM’s are performed and documented monthly.

· Troubleshoot for all equipment in the department in collaboration with Packaging Mechanics when needed.

· Contacts equipment vendors when mechanical problems arise.

· Performs required analysis of all electrical, electronic, and mechanical components in the event of equipment failure.

· Hands on equipment validation and testing of expected mechanical performance against packaging requirements.

· Establish and perform preventive maintenance on all equipment to ensure proper operation and minimal downtime.

· Performs set-ups and changeovers of all machines in accordance with schedule demands.

· Evaluate, recommend, develop, and implement packaging materials/systems based on multiple factors and influence (i.e., operations, regulatory, marketing, quality, artwork, etc.)

· Perform and/or coordinate material and packaging system testing as required by regulatory filing requirements.

· Develop and execute test protocols and reports.

· Collaborate with external customers and internal manufacturing sites on packaging development.

· Support packaging component and/or equipment selection and validation

· Problem solve quality deviations that occur during manufacturing operations

· Participate in QA investigations when needed.

· Collaborate with key stakeholders to provide technical assessments and support for key component changes.

· Partner with Global Procurement to execute on aligned strategy, from vendor identification to implementation.

· Manage scale up of new products, manufacturing feasibility batches, writing batch records and summarizing results.

· Determine appropriate use of packaging equipment and processes to ensure acceptable product stability is obtained for all packaging operations.

· Develop and execute studies for process, equipment, cleaning, facility, computer, and utility validation activities related to bulk drug delivery and finished dosage formulations developed by R&D and products currently in commercial production, customer, and FDA requirements.

· Update, review, and approve Standard Operating Procedures (SOPs) and other official documents and determine if validation or re-validation is needed prior to approval of new or changed procedures. Recommend new procedures or revisions were applicable.

· Collaborate with validation projects within the facility including execution of protocols and report writing.

· Support engineering department with capital projects or trouble shooting of equipment and processes within the facility.

· Contributor of lean manufacturing and continuous improvement programs within the facility



PACKAGING MECHANICAL ENGINEER REQUIRED SKILLS AND QUALIFICATIONS:

· Bachelor’s degree in engineering or related technical field and 6+ years' experience in a GMP industry

· Deep mechanical knowledge of GMP packaging equipment

· Project management experience

· Lean manufacturing skills

· General knowledge of solid oral dose processing is a plus.

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