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Packaging Development Specialist
2 months ago
We are seeking a highly skilled Packaging Development Specialist to join our team at Thermo Fisher Scientific. As a key member of our organization, you will be responsible for designing, modifying, supporting, and improving packaging processes at the development, validation, and commercial stages for our clients.
Key Responsibilities- Technical Leadership: Provide technical leadership for the design and evaluation of packaging processes, focusing on Quality by Design and the use of technology and automation to achieve repeatable, efficient, and safe processes.
- Problem Solving: Lead and/or participate in problem-solving for packaging activities, equipment, and processes, ensuring timely and effective resolution.
- Documentation: Prepare documentation for Risk Assessments, Engineering Line Trials, and Packaging Development Reports for assigned clients, ensuring compliance with regulatory requirements.
- Master Batch Records: Prepare Master Batch Records for Pharmaceutical Development Services and Commercial Operations for assigned clients, driving required changes through change controls as needed.
- Client Support: Provide packaging expertise and project support to clients during meetings and on-site visits, ensuring effective communication and collaboration.
- Collaboration: Collaborate with Project Management, Business Management, Process Pharmacy, Technical Transfers, Validation, Planning, Materials Management, Analytical, and other functional areas to meet project and team objectives.
- Flexibility: Perform alternating or rotating shifts as required, demonstrating adaptability and flexibility in a fast-paced environment.
- Education: College/Technical School diploma in a relevant technical field.
- Experience: Minimum 3 years of 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: General understanding of drug packaging processes, organizational skills, technical writing and oral presentation skills, general knowledge of experimental design, and familiarity with current Good Manufacturing Practices.
- Environmental Health & Safety: Follow all Environmental Health & Safety Policies and Procedures, ensuring a safe and healthy work environment.
- Teamwork: Work collaboratively with fellow team members, modeling positive team principles and partnering to meet project and departmental objectives.
- Quality Systems: Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP).
- Client Focus: Be client and patient conscious at all times, understanding Key Performance Indicators and striving to improve the performance of the team by identifying areas for system improvements and engaging in problem-solving.
Light physical effort and fatigue, with occasional equipment operation and lifting of light items. Typically located in a comfortable indoor area, with regular exposure to mild physical discomfort from factors such as dust, fumes, or odors, temperature extremes, loud noise, strong drafts, or bright lights.
BenefitsWe offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company savings plan, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.