Instrumentation Scientist II - Whitby, Canada - Thermo Fisher Scientific

Description

Job Description


Summary:
Calibrates and qualifies all new and existing analytical equipment according to a set schedule and current
Patheon Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and corporate quality standards.

Essential Functions:
Conducts maintenance and calibrations for each new and existing piece of analytical equipment in
accordance with a schedule. Meets standard hours for tasks assigned.
Troubleshoots and repairs malfunctioning apparatus independently.
Maintains detailed and accurate records to meet all regulatory and user requirements.
Proficiency with Trackwise to open and close change control activities.
Follows all current SOPs and procedures.
Maintains a safe working environment and reports potential hazards.
Limited travel to other local sites (as required)
Ability to respond to emergency after-hours (as required)
Perform alternating or rotating shift work (as required)

REQUIRED QUALIFICATIONS

Education:
Community College in Chemistry or related field
B.Sc. in chemistry or a related field an asset.

Experience:
Minimum 3 years of instrumentation validation experience in a pharmaceutical industry or related field.
Minimum of 2 years of experience performing analytical testing as assigned for on prototype to commercial
batches supporting development and/or manufacturing operations OR
Minimum 1 year demonstrated proficiency as an Instrumentation Scientist I

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

Knowledge, Skills, and Abilities:
Good understanding of basic chemistry and experience with common laboratory equipment and operation.
Knowledge of Good Lab Practices and Good Manufacturing Practices. Strong computer proficiency with
lab software and Microsoft (MS) Office programs. Excellent communication skills (both oral and written).
Ability to meet deadlines and prioritize. Detail oriented with excellent organizational skills. Good
understanding of quality and regulatory requirements in the pharmaceutical industry. Good problem-solving
skills and logical approach to solving problems. Ability to meet deadlines and prioritize work. Works well
in a team environment and cooperates with other members of the team to find a solution. Self-motivated
with the ability to meet multiple deadlines. 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 Standard Operating Procedures
(SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion.
Actively engage in and adhere to departmental systems 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
Instrumentation Scientist II Page 2 of 3
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 lab/lab 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 10-35 pounds; arm, hand and finger dexterity, including
ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor,
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. Use of Personal Protective equipment may be required
and may include any of the following: Safety glasses, safety shoes, lab coat, latex or similar gloves, safety
apron, organic respirator occasionally.