Packaging Engineer

PPL Healthcare•Sellersville, PA

1d•Onsite

About The Position

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. This critical role provides technical oversight, improvements, troubleshooting, support, and project leadership in the Sellersville Manufacturing Packaging area. The Packaging Engineer serves as the subject matter expert (SME) for serialization for the SLV Packaging line by creating recipes, testing and validating global serialization programs. They partner with Operations Excellence to implement various lean improvement techniques to improve the OEE, and help troubleshoot equipment and processes as well as improvement projects. The role also involves proposing, designing and managing various Packaging capex projects, leading individual and team efforts for quality investigational events using a lean methodology, and initiating, writing and executing validation protocols following applicable cGMP and SOPs. Additionally, the Packaging Engineer supports the development of new packaging components and integrated closure systems, reviews and approves packaging material and component specifications, and conducts RCA of any packaging component related complaints. They also support QA and RA teams on technical reports and documentation, develop and implement operator training, and initiate projects that will increase packaging output (bottles) on packaging line and improvement to processes.

Requirements

Bachelor’s degree or relevant equivalent experience
Must have 5+ years’ experience in packaging engineering or packaging development
Proficiency in 3D CAD Software; Solidworks, AutoCad, etc.
Strong mechanical aptitude
Excellent verbal and written communication skills
Creative and able to present various solutions
Understanding process improvement, quality improvement concepts
Understanding of DMF requirements for filing in a global market
Energetic, enthusiastic, and motivational disposition
Ability to work independently and as a part of a team
Effective problem solving and decision-making skills
Ability to multi-task being able to manage multiple projects simultaneously

Responsibilities

Provides packaging engineering, packaging equipment and packaging component expertise to improve costs, efficiencies, and meets production targets
Serves as the subject matter expert (SME) for serialization for the SLV Packaging line by creating recipes, testing and validating global serialization programs
Partners with Operations Excellence to implement various lean improvement techniques to improve the OEE
Helps trouble-shoot equipment and processes as well as improvement projects
Proposes, designs and manages various Packaging capex projects
Leads individual and team efforts for quality investigational events using a lean methodology (cause and effect diagrams, SIPOC, 5Y's etc.) to reduce quality defects produced on the packaging line
Initiates, writes and executes validation protocols following applicable cGMP and SOPs
Supports development of new packaging components and integrated closure systems
Reviews and approves packaging material and component specifications
Conducts RCA of any packaging component related complaints
Support QA and RA teams on technical reports and documentation needed to support any quality investigations and regulatory submissions
Develops and implements operator training
Writes and executes packaging studies, validation protocols, SOPs and training plans
Initiates projects that will increase packaging output (bottles) on packaging line and improvement to processes
Other duties as required