Sr. Associate, Quality Control Lab - Analytical Science & Technology (AS&T)

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

The Laboratory Sr. Engineer - Instrument Qualification & Method Validation is responsible for ensuring the quality and reliability of analytical and microbiological testing within the laboratory. This role focuses on the planning, execution, and documentation of instrument qualification and method validation activities, ensuring compliance with regulatory requirements and internal standards. The ideal candidate will have a strong understanding of laboratory procedures, quality systems, and relevant regulatory guidelines (e.g., GMP, GLP, ISO).

Responsibilities:

• Instrument Qualification:
  • Develop and execute qualification protocols (IQ, OQ, PQ) for laboratory instruments used in analytical and microbiological testing, including but not limited to: HPLC, GC, spectrophotometers, incubators, autoclaves, etc.
  • Manage the qualification lifecycle, from planning and execution to documentation and reporting.
  • Troubleshoot instrument issues and collaborate with vendors for repairs and maintenance.
  • Maintain accurate records of all qualification activities, including protocols, reports, and calibration certificates.
  • Ensure instruments are calibrated and maintained according to established schedules and procedures.
  • Identify and implement improvements to the instrument qualification process.
• Method Validation:
  • Develop and execute method validation protocols for analytical and microbiological test methods, ensuring compliance with regulatory requirements and internal standards.
  • Evaluate method performance characteristics, including accuracy, precision, linearity, specificity, and robustness.
  • Prepare validation reports summarizing the results and conclusions of validation studies.
  • Collaborate with method development scientists to optimize and transfer new methods.
  • Maintain accurate records of all method validation activities, including protocols, reports, and data.
  • Stay current with regulatory guidelines and industry best practices for method validation.
• General Laboratory Support:
  • Assist in the development and maintenance of laboratory SOPs and other quality documents.
  • Train laboratory personnel on instrument operation, qualification procedures, and method validation techniques.
  • Participate in laboratory audits and inspections.
  • Maintain a clean and organized work environment.
  • Perform other duties as assigned by the supervisor.

Qualifications:

• Bachelor's degree in Chemistry, Microbiology, Biology, Pharmaceutical, or a related scientific field.
• Proven experience (5 years) in a laboratory environment, preferably in a regulated industry (e.g., pharmaceutical, biotech, food).
• Strong understanding of GMP, GLP, ISO, and other relevant regulatory guidelines.
• Experience in instrument qualification (IQ, OQ, PQ) and method validation.
• Familiarity with a variety of analytical and microbiological testing techniques.
• Excellent documentation and record-keeping skills.
• Strong analytical and problem-solving skills.
• Ability to work independently and as part of a team.
• Excellent communication and interpersonal skills.

Preferred Qualifications:

• Experience with specific laboratory instruments (e.g., HPLC, GC, MS).
• Knowledge of statistical software (e.g., Minitab, JMP, GraphPad Prism).
• Experience with LIMS systems.