Primary Objective of Position
Plans, organizes, leads and controls all aspects of the calibration function on site. Acts as primary interface between Facilities Department and other department on calibration matters. Supervises calibration and instrument maintenance contracts.
• Plans and organizes required calibrations and maintenance.
• Implements creation of calibration and maintenance records as required by Site SOPs.
• Reviews and approves calibration and maintenance reports as required by Site SOPs.
• Develops procedures to ensure compliance with required calibration and maintenance standards.
• Acts as primary interface between Facilities Department and other departments on calibration matters
• Plans, negotiates and manages execution of process and analytical equipment calibration contracts.
• Reviews and approves specifications for new instruments and analytical equipment
• Plans, organizes and executes projects related to field of expertise
• Ongoing professional development in field of expertise.
Lead or Supervisory Responsibilities
Supervises work of others, including planning, assigning, scheduling and reviewing work, ensuring quality standards. Is responsible for hiring, terminating, training and developing, reviewing performance and administering corrective action for staff (may be subject to final approval by leadership). Plans organizational structure, position content and staffing.
Minimum Job Qualifications
Bachelor’s degree in related engineering or science discipline.
• At least eight (8) years of related experience, including at least five (5) years direct experience in calibration and maintenance of pharmaceutical manufacturing / QC / R&D equipment instrumentation.
Licenses, Certificates, Registrations
• Documented training in fundamentals of calibration
• Documented training in fundamentals of cGMP
• Minimum 3 years supervisory experience required
• American Society Quality -Certified Quality Technician preferred
• Ability to analyze and resolve complex problems in terms of fundamental engineering and / or scientific principles
• Ability to apply calibration principles to the development of procedures, specifications and standards for instruments and equipment new to the site
• Ability to execute, document and present investigations into calibration-related issues
• Ability to apply project management principles to new projects and plan, organize and execute such projects
• In depth knowledge of computerized calibration management systems preferred.
• Working knowledge of solid oral dose R&D and commercial manufacturing equipment, including ongoing inspection and maintenance requirements preferred.
• Sound knowledge of pharmaceutical validation standards and practices preferred.
• Working knowledge of analytical equipment, including calibration standards and procedures preferred.
Physical and Mental Demands and Work Environment
The physical and mental demands and work environment described her are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk and sit. The employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch,
The employee must 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 the ability to adjust focus. Able to distinguish colors on color-coded items correctly.
While performing the duties of this job, the employee is regularly required to use English written and oral communication skills; interact appropriately with staff, manage contractors, vendors and other encountered in the course of work; read and interpret a variety of documents and instructions furnished in written, oral, diagram, or schedule form such as safety rules, operating and maintenance instructions, and procedure manuals; collate and interpret technical and engineering data; generate technical reports of investigations; analyze and solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; establish priorities and work on multiple assignments and projects concurrently.
The employee is regularly required to apply computer skills covering word processing, spreadsheet and presentation software.
The employee is regularly required to apply mathematical formulae and calibration rules of thumb to tasks and execute technical and calibration-related calculations.
In certain assignments, the employee will occasionally work near moving mechanical parts or energized electrical systems. The employee will occasionally work around fumes, airborne particles and chemicals, which may require the employee to wear specified Personal Protective Equipment
Generally office based, with regular movement into and out of manufacturing, QC, R&D and mechanical areas.
The noise level in the work environment is usually quiet to moderate, but may occasionally be loud.
Special Working Conditions