Shire Jobs

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

How will you make an impact:

Support/Lead packaging equipment and client packaging development projects from initial design to ongoing commercial production.

What will you do:

• Lead the Project Management for implementation of packaging equipment, new market launches and serialization requirements where applicable.

• Work with Global Serialization team and outside Vendors to coordinate changes to Serialization systems.

• Write protocols / reports for packaging engineering line trials.

• Support coordination and execution of engineering line trials that involves components, scheduling, training, documentation, serialization, etc.

• Support packaging equipment projects.

• Own the completion of equipment Corrective Action Preventative Actions (CAPA's).

• Support implementation of improvements into batch records.

• Liaise with functional areas (including clients and vendors) to meet objectives.

• Perform alternating or rotating shift work as required.

How will you get here:

Education:

College/Technical School diploma in relevant technical field.

Experience:

Minimum 3 years of previous related experience and general knowledge of a drug packaging, validation or packaging production.

Experience in packaging technical/scientific discussions with clients.

Previous Project Management experience an asset.

Equivalency:

Equivalent combinations of education, training, and meaningful work experience may be considered.

Knowledge, Skills and Abilities:

General understanding of drug packaging processes and sterilization. Good Manufacturing Practices, Standard Operating Procedures and Food and Drug Administration (FDA) compliance knowledge. Demonstrates 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 the 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 an appreciation for client service and the contract manufacturing industry. 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, 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.

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.