Metrologist

Job Summary:
The Metrologist in the pharmaceutical industry is responsible for ensuring the accuracy, precision, and reliability of measurement instruments and equipment used in the production, quality control, and research and development processes. This role involves calibration, maintenance, and validation of equipment to comply with regulatory standards and ensure product quality and safety.

Key Responsibilities:

• Calibration and Maintenance:
• Perform routine calibration of laboratory and production equipment, including but not limited to balances, pipettes, pH meters, HPLC systems, and other analytical instruments.
• Develop and implement calibration schedules and procedures to ensure all equipment is calibrated according to manufacturer specifications and regulatory requirements.
• Maintain calibration records and documentation in compliance with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
• Equipment Validation:
• Participate in the validation and qualification of new equipment, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Collaborate with quality assurance and validation teams to ensure equipment meets regulatory and company standards.
• Troubleshooting and Repairs:
• Diagnose and troubleshoot issues with measurement instruments and equipment.
• Coordinate with external vendors for repairs and maintenance when necessary.
• Ensure minimal downtime by promptly addressing equipment malfunctions.
• Regulatory Compliance:
• Ensure all metrology activities comply with regulatory standards such as FDA, EMA, and ISO guidelines.
• Participate in internal and external audits, providing necessary documentation and support.
• Stay updated with changes in regulatory requirements and industry best practices.
• Documentation and Reporting:
• Prepare and maintain detailed records of calibration, maintenance, and validation activities.
• Generate reports and certificates of calibration for internal and external stakeholders.
• Ensure all documentation is accurate, complete, and readily available for review.
• Continuous Improvement:
• Identify opportunities for process improvements in metrology practices.
• Implement new technologies and methodologies to enhance measurement accuracy and efficiency.
• Provide training and support to staff on proper use and maintenance of measurement equipment.

Qualifications:

• Education: Bachelor’s degree in Metrology, Engineering, Chemistry, or a related field. Advanced degree or certification in Metrology is a plus.
• Experience: Minimum of 2-5 years of experience in metrology, preferably in the pharmaceutical or biotechnology industry.
• Technical Skills: Proficiency in using calibration tools and software. Knowledge of analytical instruments and their calibration requirements.
• Regulatory Knowledge: Familiarity with GMP, GDP, FDA, EMA, and ISO standards.
• Attention to Detail: High level of accuracy and attention to detail in calibration and documentation.
• Problem-Solving: Strong analytical and problem-solving skills to troubleshoot equipment issues.
• Communication: Excellent written and verbal communication skills for effective documentation and collaboration.

Work Environment:

• Laboratory and production settings within a pharmaceutical manufacturing facility.
• May require occasional overtime or weekend work to meet production schedules or address urgent equipment issues.

Physical Requirements:

• Ability to lift and move equipment weighing up to 50 pounds.
• Manual dexterity for handling small tools and instruments.

Job Type: Full-time

Pay: $75,000.00 - $95,000.00 per year

Benefits:

• 401(k)
• Health insurance
• Paid time off

Schedule:

• 8 hour shift

Ability to Commute:

• Hauppauge, NY 11788 (Required)

Ability to Relocate:

• Hauppauge, NY 11788: Relocate before starting work (Required)

Work Location: In person

Salary : $75,000 - $95,000