Sr. Automation Compliance Specialist

Employer
Pfizer
Location
Rocky Mount, North Carolina, United States
Posted
Nov 07, 2020
Ref
4793168
Required Education
Bachelors Degree
Position Type
Full time
ROLE SUMMARY

The Sr. Automation Compliance Specialist is esponsible for contributing to the Automation Compliance program at the Site including but not limited to SOPs revisions, CAPAs, QARs, CRs, commitments, periodic reviews, validation master plans, compliance to PQS, audits, etc.

Develops and review Automation Computer System Validation Life Cycle related documentation. Perform Gap Analysis and Risk Assessments to Automation engineering Systems. Evaluate Change Control requests associated with Automation supported systems in compliance with the Corporate, local, and cGMP requirements to determine the appropriate actions to be followed for GMP and non-GMP systems as required. Provide technical support for 21 CFR Part 11, EU Annex 11, and Computer System Validation (CSV) efforts.

Display strong investigative or technological orientation with independence. Display initiative and commitment. The incumbent is able to make independent contributions to the development of new methodologies or new technologies. Contribute to long-term strategic development of site process control systems. The incumbent has demonstrated ability to plan multiple projects and initiatives independently under minimum supervision. Perform functions to provide technical support on compliance matters related to the Automation engineering systems. Mentor and guide junior staff and serve as a technical trainer whenever necessary.

Uses own judgment to modify standard methods and techniques when necessary. Develop processes that lead to shortened cycle time and makes major impact on operational decisions.

Demonstrate proficiency in cGMP, GAMP, software development life cycle, environmental, health and safety procedures to assure compliance with regulatory, policies and/or established guidelines. Observe and notify any risk situation for the environment, health or safety. Assure that all automation engineering initiatives comply with all regulatory agency requirements.

ROLE RESPONSIBILITIES
  • Support all investigations related to Automation engineering systems (QARs). This may include performing the data gathering for the investigations, write the reports, provide compliance input, and coordinate meetings with all the affected parties.
  • Track and follow-up on timely completion of CAPAs (Corrective and Preventive Actions) that result from investigations, audits, PQS compliance assessments, and others.
  • Track and follow-up on timely revisions of Automation engineering related SOPs with owners.
  • Review and pre-approve all CRs (Change Requests) related to Automation engineering systems and projects.
  • Act as the Automation technical resource for all regulatory and internal audits and inspections. This includes reviewing all information provided to auditors.
  • Perform gap analysis on Automation engineering systems with regard to PQS compliance.
  • Review automation Verification and /or C&Q documentation on Automation engineering projects and initiatives.
  • Perform analysis on Automation engineering system incidents and failures and identify root causes and possible corrective actions.
  • Provide training to Pfizer colleagues and contractors on Automation Compliance SOPs.
  • Monitor, generate and/or complete the periodic review, validation master plan for the Automation engineering program.
  • Provide technical support to all Engineering colleagues on Automation Compliance issues.
  • Provide technical support for Automation engineering systems issues were applicable.
  • Maintain and issue the monthly Key Performance Indicators of the Automation Engineering Program.


BASIC QUALIFICATIONS
  • Bachelor's degree in Engineering required, (Chemical, Computer, Mechanical or Electrical), or Computer Systems preferred
  • 3 years of experience is required
  • Strong knowledge of Computerized Systems Compliance regulations and standards including but not limited to cGMP, EU, GAMP, ISA, etc.
  • Experience on Automation Compliance projects including but not limited to PLC's, HMI's, DCS, Historians, Industrial Data Networks, Instrumentation and related systems (hardware / software).
  • Knowledge of GMP, OSHA, FDA, and/or environmental regulations applicable to the Pharmaceutical Industry.
  • Experience supervising contractors including but not limited to project engineers, software developers, compliance specialists, etc.
  • Experience with process controls equipment including PLCs, DCSs, HMIs, SCADA systems, SQL relational database systems, and Network infrastructure including design and testing skills.
  • Strong verbal, writing and communication skills


PHYSICAL/MENTAL REQUIREMENTS

Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and complex data analysis, problem solving. Ability to work in a gown room conditions. Ability to write general correspondence and technical reports. Requires good written, oral communication and presentation skills. Requires good planning, organizing, time management and team participation skills.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Regular Work Schedule:
  • Standard (M-F) daytime. Overtime work may be required. Work requires on-site presence. Occasional national/international travel for equipment factory acceptance testing, training seminars, vendor meetings, work progress meetings, etc.

Non-Regular Work Schedule:
  • At different times of the year, this position will work long hours for scheduled manufacturing shutdown periods and throughout the year may be required to work late with little notice as need arises when equipment is unexpectedly down.


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

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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