Instrumentation Scientist II

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:

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:

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  

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 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.

Compensation

The salary range estimated for this position based in Ontario is $62,000.00–$93,050.00.