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POSITION SUMMARY: 

The Calibration Technician IV is responsible for the calibration, maintenance, testing, troubleshooting and repair of test and measuring equipment in laboratory and in manufacturing facilities including but not limited to analytical, process and manufacturing equipment. Analyze, test and calibration results, and may develop test specifications and electrical schematics.  Maintains all logs and required documentation.  Performs analysis of calibration results and maintains calibration history files and documentation. 

ESSENTIAL FUNCTIONS:

• Develops calibration methods, identifies and procures the required standards. Reviews and approves calibration SOPs.
• Performs scheduled, demand, new and emergency calibrations on laboratory/process equipment.
• Understand measurement traceability requirements.
• Implement SI units in daily metrology activities.
• Able to develop metrology data sheets, calculate equipment specifications, recommend process tolerance.
• Able to amend Standard Operating Procedures as and when needed.
• Recommend new methods and processes to improve calibration activities.
• Maintains calibration records, instrument tagging, change control documentation and deviation notifications.
• Troubleshoots moderately complex technical problems.
• Responsible for the development of calibration methods, generating of SOPs, and identifying and procuring required standards to expand laboratory capabilities.
• Trains staff in performing calibrations on all critical process equipment ensuring compliance with Standard Operating Procedures and cGMP requirements.
• Ensures that all work is done in accordance with MassBiologics procedures, Standard Operating Procedures and cGxP regulations
• Supervises Calibration staff as required; may perform evaluation of staff.
• Performs additional job-related duties as required

REQUIRED QUALIFICATIONS:

• Requires a Bachelors degree or equivalent experience and 5 to 7 years in metrology field.
• Requires a thorough understanding of metrology principles defined in ANSI/NSCL, ISO/IEC 17025 & FDA regulations
• Well versed with respect to industrial electronic and pneumatic interfaces.
• Working knowledge of PLC and other single loop control systems.
• Well versed in understanding P&ID drawings and electronic schematics.
• A solid knowledge of the physics, mathematics including statistical calculations in the following disciplines (thermodynamics, pressure, mass, flow, electrical/LF DC, chemical, etc.).
• Prior experience in a cGxP regulated environment preferred, particularly 21CFR part 11, 21 CFR part 58, etc.
• Capable of moderately complex troubleshooting
• Computer literate and proficient in MS Word, Excel and other relevant electronic systems
• Strong problem solving, time management and organizational skills.
• Demonstrated ability to multitask and consistently meet deadlines
• Possesses well developed attention to detail, ability to maintain accurate records and excellent proofreading skills
• Excellent written and verbal communication skills.
• Ability to communicate effectively with others and to train others.
• Demonstrated initiative through past experience
• Ability to work effectively both independently and as a member of a team
• May require occasional weekend work via beeper coverage