PharmEng Technology Looking for Packaging Project Manager at Valparaiso, IN

 Responsibilities:

• The Packaging Project Manager will be responsible for ensuring the process and process equipment meet compliance, safety, and business requirements on a day-to-day basis, as well as respond to alarms, Out of Specs, Out of Tolerances, etc. to ensure product impact assessments are performed as necessary.
• Troubleshoot equipment to determine root cause of failure modes, own Corrective/Preventative Actions & associated change controls, provide input on preventative maintenance plans, assess change controls, and spearhead continuous improvement initiatives.
• Own quality records such as Change Controls, Deviations, and CAPAs related to manufacturing process equipment, and employ high quality technical writing within the required quality systems to ensure the manufacturing schedule is not impacted.
• Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment and update as required.
• Acting as an owner, provide engineering support for process equipment procurement and start-up at Organization’s manufacturing facility (Incubators, Centrifuges, Fermenters, Ultrafiltration, Chromatography, Manual & Robotic Filling Lines, Visual Inspection Machines, Label/Pack Lines, Buffer Prep Vessels, etc.).
• The Packaging Project Manager will participate on project teams through all phases of engineering projects related to process equipment including development of user requirements, conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.
• Review design documentation from conceptual through detailed design, URS documents, and Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment and update as required.

Required Qualification:

• A bachelor’s degree in chemical or mechanical Engineering or any other life science related technical field.
• Minimum of 3 years relevant experience as a Process Engineer or System Owner
• 4 years of experience in a GxP environment preferred.
• Experience with Drug Substance and Drug Product Equipment (Incubators, Centrifuges, Fermenters, Ultrafiltration, Chromatography, Manual & Robotic Filling Lines, Visual Inspection Machines, Label/Pack Lines, Buffer Prep Vessels, etc.).
• Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required.
• Must be able use his/her technical background to make informed decisions and ensure manufacturing demands are met.
• Familiarity with Excel, Word, and PowerPoint are required.
• Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.
• Ability to represent Organization’s interests, objectives, and policies in a professional and responsible manner.