Sr. Instrumentation Compliance Engineer

Employer
Pfizer
Location
Rocky Mount, North Carolina, United States
Posted
Nov 06, 2020
Ref
4795333
Required Education
Bachelors Degree
Position Type
Full time
ROLE SUMMARY

The Sr. Instrumentation Compliance Engineer will manage and ensure that an effective compliance system exists for calibration/ instrumentation-related procedures, documentation, computer management, and investigations. Coordinate with Instrumentation Management oversight and complete related internal and 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, administrative and organizational are required. Other related duties may be assigned related to ensuring compliance.

ROLE RESPONSIBILITIES
  • Act as assigned owner of Instrumentation Investigations in QTS TrackWise for instrument standard calibration events, assigned CAPAs, assigned Effectiveness Checks.
  • Responsible for approving/completing/coordinating the completion of Action Items and entering proof of completion documentation.
  • Responsibilities also include review and providing feedback on all calibration/instrumentation related investigations.
  • Conduct internal audits, periodic reviews, create, and edit Instrumentation procedures (SOPs and Tasks) and ensure these documents meet the quality plan and compliance expectations.
  • Participate in internal and external audits.
  • Ensure instruments are of adequate accuracy for their intended purpose (4:1 accuracy ratio, guard banding, etc).
  • Serve as the primary Calibration Coordinator in reviewing and approving added, changed, and decommissioned instrumentation records and CCMS assets.
  • Run queries, generate reports, and perform analyses on site CCMS data to support departmental, organizational, and site tasks and objectives.
  • Support, recommend, and implement new calibration standards for use by the instrumentation department
  • Support coordination of vendor calibration program.
  • Develop and maintain technical Instrumentation training program and act as the trainer for instrumentation and site CCMS user colleagues.


BASIC QUALIFICATIONS
  • BS/BA Degree is required, science discipline preferred.
  • Minimum 3 years of experience in Pharmaceutical Instrumentation environment.
  • Minimum 3 years of experience in Pharmaceutical Systems Validation experience.
  • Minimum 3 years of experience in Pharmaceutical and/or Industrial Computerized Maintenance Management Systems experience.
  • Pharmaceutical and/or Industrial technical SOP writing experience.
  • Working knowledge of FDA regulations and cGMP experience.
  • High level of Computer skills required in MS Office, Word, Excel, SAP Business Objects Reports, and CMMS systems.


PREFERRED QUALIFICATIONS
  • Validation experience in Systems/Instrumentation/Equipment
  • ISA Certified Calibration Technician and or certification by a quality-body (i.e. ASQ).
  • Experience in Enterprise Asset Management System software.
  • Prior investigation writing experience (with determination of product impact).
  • Calibration or Maintenance Planning/Management program management and/or improvement.
  • Organize data, extract key information and creation of technical summary reports.
  • Superior problem solving /troubleshooting skills.
  • Knowledge of various quality tools.
  • Strong oral and written communication, presentation, interpersonal skills.
  • Ability to interface with multiple levels of people in the organization, including plant personnel and senior management.


PHYSICAL/MENTAL REQUIREMENTS
  • Lifting (up to 50 pounds), sitting, standing, walking, bending, climbing ladders, ability to perform mathematical calculations, ability to perform complex data analysis, and ability to perform computer data entry.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Must be able to work overtime as required including weekends, off-shift, staggered-shift, holidays, shutdowns, projects, and as required. Must be available for on-call work as needed. Must adhere to safe work practices. Train on all required procedures and qualify for aseptic gowning.


Other Job Details:
  • Last Date to Apply for Job: 11/27/20
  • Eligible for Relocation Package
  • Eligible for Employee Referral Bonus
  • #LI-PFE


Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Engineering