Process Engineering Specialist

2 months ago

Whitby Ontario LB, Durham region, Canada Thermo Fisher Scientific Inc. Full time

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

Summary:

Assist with Technical Data analysis for the Process Engineering Specialist as it relates to development, deviation and annual reports to meet Client expectations.

Essential Functions:

  • Acquire and use practical and technical knowledge of the manufacturing processes related to pharmaceutical dosage forms

  • Complete tasks related to monitoring/trending and troubleshooting manufacturing processes

  • Assist with troubleshooting and solving problems related to process efficiency, product quality, throughput and yield

  • Assist in investigations through data compilation and statistical analysis to determine root cause to atypical events

  • Support compilation and analysis of process data. Present results and prepare reports.

  • Contribute to process improvement projects

  • Prepare and data checks technical reports.

  • Participate in change management activities.

  • Use SAP enterprise software to source information and navigate business operations

  • Support Technical Operations department with process executions.

  • Perform alternating or rotating shifts (as required)

REQUIRED QUALIFICATIONS

Education:

Enrolled in a post-secondary diploma in Chemistry, Engineering, Science or related field.

BSc in Chemistry or Engineering is an asset.

Experience:

Previous experience with Pharmaceutical Manufacturing an asset.

Previous experience with SAP enterprise software to source information and navigate business operations an asset.

Previous experience in statistical analysis and data compilation an asset.


Equivalency:

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

Knowledge, Skills and Abilities:

Strong written and oral skills. Detail oriented and organized, with a high degree of accuracy and thoroughness. Excellent interpersonal skills and communication skills. Ability to multi-task, meeting tight deadlines in a fast paced environment. Knowledge of current Good Manufacturing Practices and ability to follow Standard Operating Procedures. Proven problem solving abilities. 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:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about manufacturing/office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of up to 40 pounds; arm, hand and finger dexterity; visual acuity to operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Usually in a comfortable environment but with regular exposure to factors causing moderate physical discomfort from such things as dust, loud noise, bright lights, fumes or odour. Use of Personal Protective equipment is required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator.

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.

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