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Packaging Engineer Technician II

Who we are?

We are a French pharmaceutical industrial group, 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 10 sites on 4 continents and more than 2000 employees.

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 300 employees.

Your role

Reporting to the Packaging Engineering Lead,

The Packaging Engineer Technician II is responsible for managing and ensuring the accuracy and compliance of technical data related to packaging components within the ERP system. This role involves creating and maintaining commercial packaging items, managing changes to item sheets, and overseeing Master Data for packaging. They will also perform modifications to Bills of Materials (BOM) through Orders of Technical Modification (OTM). The role includes evaluating and implementing change controls for various packaging-related aspects, ensuring adherence to cGMPs and FDA regulations, and supporting Regulatory, QA, and Business Development teams. This position plays a key part in ensuring packaging components meet customer and regulatory requirements, including overseeing artwork, supplier relationships, and change controls. They will be responsible for generating and submitting artwork overlays, barcodes, and other documentation to suppliers while maintaining strong internal and external relationships to resolve any labeling issues. Additionally, the role includes managing the creation and modification of shipper labels and palletizing patterns, ensuring alignment with customer requirements, traceability, and internal logistical constraints.

ESSENTIAL DUTIES / RESPONSIBILITIES:

Manage Technical Data

•Make sure technical data is up to date in ERP system.

•Create new items for commercial Packaging Components.

•Manage changes and settings of item sheets in the ERP

•Manage Master Data in the ERP system for packaging.

•Perform the change of the BOM via an Order of Technical Modification (OTM)

Technical Compliance

•Evaluates and implements Change Controls for customer artwork revisions, packaging component specifications, supplier material or process changes, purchased component deviations, and manufacturing improvements

•Support Regulatory, QA and Business Development. Comply with cGMP’s, FDA regulations, and their proper application as they pertain to pharmaceutical labeling.

•Evaluates and implements improvements in process, design, procedures, materials and equipment to minimize cost and maximize efficiencies to achieve work goals.

•Support Regulatory Affairs, Operations, and Product Development for all matters concerning labeling components.

Artwork that Meets Customer & Regulatory Requirements

•Generates and submits appropriate overlays and barcodes specific to artwork components and specifications to customers and approved suppliers for production of printed components.

•Works directly with suppliers to provide and receive information that ensures proper order and receipt of labeling components.

•Provides support and expertise to teams and task groups to ensure timely receipt of appropriate labeling components, as well as labeling issue resolution, especially as they pertain to change controls and corrective actions.

•Develops and maintains effective working relationships with both internal and external (e.g. graphics agencies, labeling suppliers, contract manufacturers, packagers and label printers) resources to ensure support in activities, tasks and issues pertaining to packaging labeling.

•Provides project leadership, translation management, and Marketing graphic support as necessary

•Reviews own work to ensure customer revisions are captured.

•Reviews and approves proofs and color standards received from suppliers.

Manage Identification Tags and Palletizing Patterns

•Manage the creation and modification of shipper labels and palletizing plan.

•Take into account customer requirements, traceability and internal logistical constraints, knowing the specifics of Unither internal packaging equipment.

Your profile

QUALIFICATIONS/EXPERIENCE:

• Bachelor’s degree in a relevant field, such as: packaging engineering, supply chain management, pharmaceutical sciences, industrial engineering, business administration, or other related field or the equivalent educational and experience.

• Minimum 2-4 years of packaging engineering experience with mechanical file preparation or print production art background required.

• Experience with ERP Management System

• Experience working with cGMP, FDA regulations, and technical compliance in the pharmaceutical or related industries is preferred.

SKILLS:

• Ability to manage multiple projects within established deadlines.

• Excellent communication skills.

• Ability to troubleshoot and solve issues with both Mac software and hardware.

• Familiarity with barcode symbology (i.e. UPC, Code-128, Data Matrix, etc.), and PageMaker.

• Experience with pharmaceutical, medical device or consumer packaging a plus.

• Experience with Plant support as it relates to documentation and specification changes that are affected by labeling, art and print changes.

• Perform Administrative Tasks as needed.

F. PHYSICAL REQUIREMENTS/ENVIRONMENT:

• Traditional office environment, with occasional visits to other areas of the facility, including production areas, loading docks, and laboratories.

• Must be able to work on a computer for extended periods of time.

• Must wear safety glasses and other protective items as required.

Compensation range

80,000.00 - 85,000.00 USD

*The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Benefits

+ 401K Plan: Unither Matches up to 6% on Employee Contributions each pay period.

+ Retirement plan: Unither has a 4% Retirement Savings Plan contribution each year on prior year earnings.

+ Performance bonus: Hourly employees recive this pay out Quarterly and Salaried employees recieve this Annually.

+ 11 Paid Holidays per year

+ Health Insurance: Benefit Premiums Paid 100% by Unither for EE, Spouse or Domestic Partner, and Children.

+ Dental and Vision Insurance: Offered for Employee, Spouse or Domestic Partner, and children.

+ Health Savings Account (HSA): Quarterly Contributions made by Untiher in addition to Employee contributions.

+ Life insurance: 2X employees Annual salary paid by Unither. Supplemental Life Insurance offered for Employee, Spouse or Domestic Partner and Children.

Learn more about us:

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.

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

Join us and make a difference!