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

Alcon; Batam; On-site; USD 30.000 - 70.000; Full time

Job summary

Join a forward-thinking company as a Laboratory Sr. Engineer, where your expertise in instrument qualification and method validation will be pivotal in ensuring the quality and reliability of testing within a dynamic laboratory environment. You will collaborate with talented professionals, develop protocols, and contribute to maintaining high standards of compliance with regulatory guidelines. This role offers the opportunity to make a significant impact on the lives of patients and customers while working in a culture that values diversity and innovation. If you are passionate about eye care and laboratory excellence, this position is perfect for you.

Benefits

Opportunity for global project exposure

Inclusive company culture

Career development opportunities

Qualifications

• 5+ years in a laboratory environment, preferably in a regulated industry.
• Strong understanding of GMP, GLP, ISO, and instrument qualification.

Responsibilities

• Develop and execute qualification protocols for laboratory instruments.
• Collaborate with method development scientists to optimize new methods.
• Train laboratory personnel on instrument operation and qualification.

Skills

Analytical Skills

Problem-Solving Skills

Documentation Skills

Communication Skills

Teamwork

Education

Bachelor's degree in Chemistry

Bachelor's degree in Microbiology

Bachelor's degree in Biology

Bachelor's degree in Pharmaceutical

Tools

HPLC

GC

MS

Minitab

JMP

GraphPad Prism

LIMS systems

Job description

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.