ROLE SUMMARY:

The Instrumentation and Controls Compliance Team Lead will manage and ensure that an effective compliance system exists for calibration/instrumentation-related procedures, documentation, computer management, investigations, and management of Instrumentation Standards. The colleague will coordinate with Instrumentation Management oversight and complete related internal/external auditing and reporting to maintain instrumentation is in full regulatory compliance. This position will also serve as the Instrumentation primary contact for internal and external audit preparations, communications, and presentations. Strong specialized skills in computer data/management systems, training, documentation, administration and organization are required. Other related duties may be assigned related to ensuring compliance. 

ROLE RESPONSIBILITIES:

• Leads and completes Instrumentation Investigations in eQMS for instrument standard calibration events, assigned CAPAs, and assigned Effectiveness Checks.

• Review and provide feedback on all calibration/instrumentation related investigations

• Approves/completes/coordinates the completion of change control action items

• Conducts internal audits, periodic reviews, and creates/edits instrumentation procedures (SOPs and Tasks) to ensure documents and the calibration program meet the quality plan and compliance expectations

• Acts as the Instrumentation Subject Matter Expert (SME) in internal and external audits

• Ensures instruments are of adequate accuracy for their intended purpose (4:1 accuracy ratio, guard-banding, etc).

• Serves as the primary calibration coordinator in reviewing and approving added, changed, and decommissioned instrumentation records and CCMS (Computerized Calibration Management System) assets for project support

• Lead for generation, queries, reports, and performs analyses on site CCMS data to support departmental, organizational, site tasks, objectives, and maintain GMP Compliance

• Supports, recommends, and implements new calibration standards for use by the instrumentation department

• Support coordination of vendor calibration program and qualify vendors in the Supplier Management system

• Develop and maintain technical instrumentation training program and act as the trainer for instrumentation and site CCMS user colleagues.

• Primary interactions will be with Instrumentation, Utilities, Maintenance, and Manufacturing Focus Factories. Position requires interfacing with Project, Process Engineering, and Validation colleagues for the instrumentation requirements on development, installation, issues, and qualification of processes. Additional interactions with Quality and other site departments/colleagues will be required but less frequent.

Required:

• Applicant must have a bachelor's degree, science discipline preferred, with at least 2 years of experience; OR a master's degree with more than 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school
  diploma (or equivalent) and 8 years of relevant experience.

• BS/BA Degree (science discipline preferred)

• Experience in Pharmaceutical Instrumentation environment

• Experience in Pharmaceutical Instrumentation project validation support

• Experience in Pharmaceutical and/or Industrial Computerized Maintenance Management Systems

• Pharmaceutical and/or Industrial technical SOP writing experience

• Working knowledge of FDA regulations and cGMP experience

• Strong oral and written communication, presentation, interpersonal skills

Preferred:

• High level of computer skills required in MS Office, Word, Excel, SQL, SAP Business Objects Reports, and/or CMMS

• Calibration or Maintenance Planning/Maintenance program management and/or improvement experience

• Instrumentation, process, validation experience

• Proficiency in Enterprise Asset Management System software

• Prior investigation writing experience (with determination of product impact)

• Organize data, extract key information and creation of technical summary reports.

• Superior problem solving /troubleshooting skills

• Knowledge of various quality tools

• Ability to interface with multiple levels of people in the organization, including plant personnel and senior management

PHYSICAL/MENTAL REQUIRE