Instrumentation Scientist Ii

2 months ago

Whitby, Canada Thermo Fisher Scientific Full time

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.

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