R&D Technician Medical Device jobs

Dalton Pharma Services is a leading provider of integrated pharmaceutical discovery, development and manufacturing services to the biotechnology and pharmaceutical industries. We develop and manufacture innovative new products on a contract basis for our customers that bring enhanced therapeutic value and impact the lives of the patients that use them. Our customers range from the largest global pharmaceutical companies in the world to the smallest startup company. Dalton offers industry leading expertise in chemical synthesis, API production, formulation development and the manufacturing of sterile injectable products, all supported by extensive in-house analytical and quality support. This posting reflects a new vacancy within our organization.

Our Technical Services group keeps Dalton's instrumentation accurate, qualified, and audit-ready. As a Calibration Specialist II, you'll own the calibration, preventive maintenance, and qualification of analytical instruments across our QC laboratory and production areas — and you'll document that work to a cGMP standard that stands up to regulatory scrutiny.

This is a hands-on technical role with a strong documentation component. You'll be as comfortable troubleshooting an HPLC as you are authoring the protocol that qualifies it.

The position is a 12-month full-time contract. It's a good fit if you want to get productive quickly in a busy CDMO environment and are open to staying on longer term.

Responsibilities:

Calibration & Maintenance

• Calibrate and maintain a broad range of analytical instrumentation, including pH meters, Karl Fischer titrators, UV, FTIR, HPLC, and GC systems
• Troubleshoot and repair instruments, implementing appropriate corrective actions
• Perform scheduled preventive maintenance on QC laboratory and production equipment
• Calibrate temperature measuring devices, stability chambers, freezers, and refrigerators using tools such as Kaye validators, humidity generators, and pressure and differential-pressure calibrators

Qualification & Validation

• Write and execute equipment qualification protocols (IQ/OQ/PQ) for new and existing instrumentation
• Commission and decommission equipment and instrumentation
• Ensure equipment and test methods are validated and compliant with cGMP
• Participate in broader validation activities as assigned

Documentation & Compliance

• Author and review SOPs, change control records, protocols, reports, and trend reports
• Create instrument calibration, maintenance, and operation SOPs
• Prepare and, where required, validate forms and spreadsheets
• Perform spot checks and monitoring of laboratory compliance, including electronic data and audit trail review per SOP
• Review, compile, and evaluate data generated by analysts

Technical Support & Improvement

• Provide technical support, training, and troubleshooting guidance to laboratory staff
• Identify gaps in current practice and propose practical improvements
• Implement or develop new and improved analytical instrumentation techniques for QC

Education/Experience Requirement

• Degree or diploma in a science or engineering discipline
• 3+ years of experience in a QC laboratory, quality assurance, or servicing analytical instrumentation in a pharmaceutical (GMP) environment
• Sound working knowledge of the operation, troubleshooting, and repair of analytical instruments (pH meter, Karl Fischer, UV, FTIR, HPLC, GC)
• Solid working knowledge of cGMP, ICH, and FDA regulations and guidance
• Demonstrated ability to write and execute instrument validation protocols and summarize the resulting data
• Strong technical writing skills and clear verbal communication in English
• Familiarity with instrument software and the GMP requirements that apply to it

Preferred

• Experience with Agilent ChemStation, OpenLab CDS, Lab Advisor, or comparable calibration management software
• Experience with Kaye validators, humidity generators, and pressure/signal calibration equipment
• Exposure to electronic quality management systems and data integrity (ALCOA+) expectations

Work Requirements

• Meticulous — calibration and validation work requires complete accuracy in both execution and documentation
• Analytical, with sound judgment about the critical attributes and parameters that affect product quality
• Collaborative, and comfortable working alongside QC analysts, Quality, and Production
• Curious, and committed to keeping current technically

While we appreciate all applications received, only those selected for an interview will be contacted.

Pay: $32.00-$35.00 per hour

Flexible language requirement:

• French not required

Application question(s):

• Do you live in the Toronto Area (GTA)?

Education:

• Bachelor's Degree (preferred)

Experience:

• pharmaceutical QC, QA, or GMP environment: 3 years (preferred)
• repair of analytical instruments: 3 years (preferred)
• HVAC, HEPA, Autoclaves: 5 years (preferred)
• cGMP, ICH, and FDA regulations : 3 years (preferred)
• write and execute instrument validation protocols : 3 years (preferred)

Work Location: In person