ThermoFisher Scientific
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Business Title: P ackaging Component Development Specialist
Issue Date: 30.MAR.2023
Revision #: 1
Summary:
Responsible for the coordination and development of packaging component specifications; managing the change of existing or establishment of new components.
Essential Functions:
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Manage all packaging componentchanges and artwork approvals for new and revised commercial products, commercial launches, and Pharmaceutical Development Services (PDS) projects.
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Lead the development of packaging components for new commercial products, technical transfers, and PDS projects as a technical expert on the project team, participating in internal and external project meetings.
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Request for and provides pricing for all packaging components.
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Initiate SAP part requests for new packaging components.
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Develop component specifications and manage the change or establishment of new components.
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Review and approve all packaging artwork for technical requirements, i.e. die lines, print specs, standards, print process.
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Determineoptimal timing for introduction of new packaging changes to support client product changes.
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Identify risks, opportunities and contingencies as it relates to packaging and artwork development.
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Support vendors investigations regarding corrective action when required.
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Assist clients in artwork design for packaging line requirements. Provides correct technical information regarding packaging i.e. bottles, caps, foil etc to clients.
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Provide technical support for QA for quality deficiencies, and non-compliant materials.
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Standardize packaging formats to meet production development requirements of Patheon.
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Act as a technical resource to the Procurement, Operations, Business Management, and other groups.
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Collect data at the plant level to identify cost savings opportunities.
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Lead projects for the team to improve procedures and processes.
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Research new packaging materials and methods that could result in cost savings and or improve product quality.
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Write all Change Controls as they relate to Packaging Components Specifications.
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Perform alternating or rotating shifts as required
REQUIRED QUALIFICATIONS
Education:
College/Technical School diploma in related technical field
Experience:
Minimum 3 years previous related experience within a manufacturing/pharmaceutical environment.
Equivalency :
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities :
Computer literate. Working knowledge of an ERP system. Able to work directly with suppliers to establish artwork and specifications. Must be organized and able to work independently. Excellent verbal and written communication skills. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English language.
*Standards and Expectations: *
Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems SOP’s and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.
Physical Requirements:
Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.
Disclaimer:
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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