Senior Metrologist
Apply NowCompany: AAIPharma Services
Location: Pepperell, MA 01463
Description:
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.
Are you interested in joining our team?
Job Summary
The Senior Metrologist is the subject matter expert in multiple disciplines: temperature, relative humidity, CO2, voltage, pressure, time, rotation, mass, etc. Perform routine and high-end calibration of Alcami and customer equipment in-house and at customer sites. Calibration involves following documented procedures using primary and secondary precision standards. Develop, modify, execute, and approve metrology procedures, processes, and calibration certificates. Evaluate new equipment and product lines. Troubleshoot, evaluate, and make recommendations about quality issues relating to management. Help Improve lab competence, efficiency, and effectiveness. Perform testing to support the Quality Management System. Conduct lab activities in compliance with the QMS. Actively support and maintain ISO 9001 certification and ISO 17025 accreditation.
On-Site Expectations
Responsibilities
Qualifications
Knowledge, Skills, and Abilities
Travel Expectations
Physical Demands and Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand; sit and stoop, kneel, crouch, or crawl. The employee is occasionally required to walk. The employee must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts and risk of electrical shock. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.
Are you interested in joining our team?
Job Summary
The Senior Metrologist is the subject matter expert in multiple disciplines: temperature, relative humidity, CO2, voltage, pressure, time, rotation, mass, etc. Perform routine and high-end calibration of Alcami and customer equipment in-house and at customer sites. Calibration involves following documented procedures using primary and secondary precision standards. Develop, modify, execute, and approve metrology procedures, processes, and calibration certificates. Evaluate new equipment and product lines. Troubleshoot, evaluate, and make recommendations about quality issues relating to management. Help Improve lab competence, efficiency, and effectiveness. Perform testing to support the Quality Management System. Conduct lab activities in compliance with the QMS. Actively support and maintain ISO 9001 certification and ISO 17025 accreditation.
On-Site Expectations
- 100% on-site position.
- 1st Shift: Monday - Friday, 8:00am - 5:00pm.
Responsibilities
- Select, develop, modify, validate, and document calibration methods for software, hardware, and instrumentation.
- Analyze, perform, and document uncertainty analysis.
- Responsible for direct reports.
- Orchestrate proficiency testing to affirm competency.
- Provide training to technicians on general metrology principles and specific calibration procedures, sharing best practices and industry knowledge.
- Author and revise current Work Instructions, procedures and documents as needed.
- Regularly reports status of projects to management.
- Proficient in multiple calibration procedures on equipment and instrumentation.
- Perform preventive maintenance and analyze trends.
- Repair equipment and instrumentation, evaluate issues and make recommendations.
- Evaluate calibration interval and tolerance for equipment and instrumentation.
- Evaluate questionable calibration results and determine solutions.
- Relay opinions or interpretation of calibration results to customers.
- Exemplify ISO 17025, ISO 9001 and NVLAP principles.
- Supply technical support as needed for both internal issues and external customers.
- Other duties as assigned.
Qualifications
- Military, Technical School, or Associate's Degree required.
- 8+ years previous calibration experience in a GxP pharmaceutical or biotechnology laboratory services, or pharmaceutical manufacturing environment required.
Knowledge, Skills, and Abilities
- Certified Calibration Technician (CCT), Instrument Society of America (ISA).
- Formal ongoing training and seminars to increase or maintain industry knowledge.
- Computer literacy, especially in Microsoft Windows, Word, Excel, Outlook, and Form Docs.
- Metrology, electronic, electrical, and mechanical skills.
- Strong written and verbal communication skills.
- Honesty, integrity, and confidentiality.
- Excellent reporting skills.
- Strong organizational and time management skills.
- Proficiency in GxP guidelines.
- Soldering experience.
Travel Expectations
- Less than 10% travel expected. Off-site travel as needed to support business needs.
Physical Demands and Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand; sit and stoop, kneel, crouch, or crawl. The employee is occasionally required to walk. The employee must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts and risk of electrical shock. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.