Packaging Engineering Project Specialist III at Thermo Fisher Scientific

Mississauga, Ontario, Canada

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, ManufacturingIndustries

Requirements

College/Technical School diploma in relevant technical field (or equivalent combination of education, training, and relevant work experience)
Minimum 3 years of previous related experience with general knowledge of drug packaging, validation, or packaging production
Experience in packaging technical/scientific discussions with clients
Previous Project Management experience (an asset)
General understanding of drug packaging processes and sterilization
Knowledge of Good Manufacturing Practices (GMP), Standard Operating Procedures (SOP), and FDA compliance
Demonstrated organizational skills relevant to drug packaging
Strong technical writing and oral presentation skills
General knowledge of experimental design
General understanding of drug product validation and communication
Ability to recommend improvements relating to pharmaceutical packaging, equipment, processes, and systems
Actively acquires new skills/knowledge relevant to drug packaging process; draws on experience and demonstrates innovative approach
Works autonomously under general direction to meet project and team objectives
Established quality, regulatory, and production mentality, including appreciation for client service and contract manufacturing industry
Demonstrated computer proficiency with Microsoft Office programs
Proficiency with the English language
Extensive knowledge and understanding of drug packaging processes, drug product validation, and commercialization processes
Extensive knowledge and experience with experimental design
Detail oriented and organized, with a high degree of accuracy and thoroughness

Responsibilities

Support/Lead client packaging development projects from initial design to ongoing commercial production
Lead Project Management for implementation of project-specific packaging equipment, new market launches, and serialization requirements where applicable
Work with Global Serialization team and outside Vendors to coordinate changes to Serialization systems
Contribute to the development of Risk Assessments, Packaging Engineering Line Trial protocols/reports, and Packaging Master Batch Records
Participate in the development of client packaging serialization requirements
Support qualification of ERP systems related to serialization
Support coordination and execution of engineering line trials (involving components, scheduling, training, documentation, serialization, etc.)
Manage completion of equipment Corrective Action Preventative Actions (CAPAs)
Support implementation of improvements into batch records
Liaise with functional areas (including clients and vendors) to meet project objectives
Participate in continuous improvement activities as needed
Maintain a safe working environment and report potential hazards
Perform alternating or rotating shift work as required
Adhere to all Good Manufacturing Practices (GMP) Safety Standards

Skills

Key technologies and capabilities for this role

Packaging EngineeringProject ManagementSerializationGMPRisk AssessmentsLine TrialsCAPAERP SystemsValidationBatch Records

Questions & Answers

Common questions about this position

What education and experience are required for this role?

A College/Technical School diploma in a relevant technical field is required, along with a minimum of 3 years of previous related experience and general knowledge of drug packaging, validation, or packaging production.

What key skills are needed for the Packaging Engineering Project Specialist III position?

Candidates need a general understanding of drug packaging processes and sterilization, knowledge of Good Manufacturing Practices, FDA compliance, strong technical writing and oral presentation skills, and proficiency with Microsoft Office programs.

Is this a remote position, or does it require on-site work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this position?

Strong candidates have previous project management experience, experience in packaging technical/scientific discussions with clients, an innovative approach, the ability to work autonomously under general direction, and a quality, regulatory, and production mentality with appreciation for client service.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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