Packaging Engineer

Packaging Engineer

Company

We are a pharmaceutical group, founded in 1993 in Amiens (North of France), recognized for making affordable healthcare products that improve and simplify patients' lives to as many people as possible.

With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 11 sites on 4 continents and more than 1600 employees. 

We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees. Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives. We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential. 

Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees.

We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility. 

Role

Reporting to the Supply Chain Manager,

JOBSUMMARY:
The Packaging Engineer for Labeling and Printed Components is botha technical and strategic leader in the selection, specification, regulatorycompliance, and change management of all printed packaging and labelingcomponents. To be successful, the Packaging Engineer must act as a key contactinternally, with our customer's labeling and artwork teams, and with oursuppliers for all component changes including artwork revisions, assessment ofnew and/or modified materials, investigation and resolution of non-compliantcomponents, new product development, and regulatory documentation.   The Packaging Engineer may assume the roleof project leader for packaging redesign, and ensures that technical support isprovided to Purchasing, QA/QC, Operations, Product Development, and RegulatoryAffairs for all matters concerning artwork, labeling, and secondary andtertiary components. 

ESSENTIALDUTIES / RESPONSIBILITIES: 
PackagingComponents and Labeling/Artwork that Meets Customer Requirements
-Defines printed component and labeling strategy in support of Sourcing goals, Approved supplier strategy, ERP structure, Quality systems and other synergies.
-Establishes and maintains Secondary and Tertiary Packaging specifications and source files for all labeling and printed components including both structural and graphic designs.
-Evaluates and implements Change Controls for customer artwork revisions, supplier material or process changes, purchased component deviations, and manufacturing improvements. Leads teams as needed to close CAPAs according to required timelines.
-Responsible for integration of customer's labeling requirements with Unither technical requirements. Collaborates with Graphic ---Designer (customer, internal, or subcontractor) to create Regulatory approved artwork released for production that meets customer implementation timing.
-Creates and modifies shipper pallet patterns in appropriate software (ie TOPS) as an input to work instructions for Packaging operations; provides to customers as requested for Distribution, ERP set up, etc.
-Supports New Product Launch teams with packaging, labeling, and printing technical expertise, associated specification creation or updates, artwork, labels, and pallet patterns.
-Technical resource with regard to printing processes, material characteristics (substrates, adhesive, inks, etc.), and impacts of changes; actively participates in project teams where expertise is beneficial
-Interfaces with Engineering where needed, in support of Line Trials for new and component changes 
-Supports Regulatory, QA and Business Development
-Stays up-to-date on cGMP's, FDA regulations, industry standard labeling and printing processes applicable to the pharmaceutical industry.
-Proactively seeks component changes leading to improvements in cost, supply reliability, product protection and handling, or user convenience.

Effective& Efficient Processes
-Ensures the development, documentation, and implementation of standardized processes for key business functions.  Develops quantitative techniques to monitor process performance.
-Evaluates effectiveness of package engineering documentation and SOPs.  Identifies changes that would enhance the process and ensures that all change control documentation is implemented.  
-Identifies and implements ways to streamline and improve efficiency while maintaining process effectiveness.Challenges the way it has always been done.
-Utilizes understanding of regulatory environment and industry trends to identify ways to improve process quality and compliance.
-Identifies the impact of available technology on business processes and ensures that it is used to maximum advantage
-Ensures stakeholders are appropriately trained on the process and any process changes.

 Profile

QUALIFICATIONS/EXPERIENCE:
-Associates degree with 8 years'experience in Packaging Design/Engineering, preferably with Graphicsexperience.
-Bachelor's degree with 4 years' experience in PackagingDesign/Engineering, preferable with Graphics experience.
-4 years' experience in the pharmaceutical industry in amanufacturing or packaging environment highly preferred

SPECIFICSKILLS:
-Strongproblem solving and investigation techniques.
-Excellent written and oral communication skills.
-Demonstratedperformance in project management.
-Strong organizationskills with the ability to multi-task in a dynamic environment and balancemultiple priorities. 
-Must becapable of working independently, with self-initiative, self-motivation, andself-strategic direction, while also effectively working within team and matrixenvironment to influence and guide activity.
-Solidunderstanding and interpretation of Regulatory guidance documents and filingmechanisms.

PHYSICALREQUIREMENTS/ENVIRONMENT: 
-Traditionaloffice environment, with frequent visits to other areas of the facility,including production areas, loading docks, and laboratories.
-Must beable to work on a computer for extended periods of time.
-Must wearsafety glasses and other protective items as required.
-Theability to read, write and communicate in English.
-Sittingapproximately 50% of day and standing approximately 50% of day. 
-Workresponsibilities may involve repetitive use of the hands through keyboarding,simple grasping, and fine manipulation.
-Normaloffice environment and occasional controlled environment work that may requireremoval of jewelry and cosmetics. 
-Occasionallysubjected to weekend, holiday, and irregular hours. 

Join us and make a difference!