Engineering Validation Manager

Employer
Pfizer
Location
Sanford, North Carolina
Posted
Jul 30, 2021
Ref
4819989
Required Education
Bachelors Degree
Position Type
Full time

ROLE SUMMARY

  • The position will provide validation support for all cGMP/GLP equipment, instrumentation, facilities and utilities at the Sanford site related to the manufacture of biological drug substances and drug substance intermediates.
  • The position leads and/or participates in the planning, preparation and execution of validations for cGMP/GLP equipment, instrumentation, facilities and utilities. This includes generation and execution of protocols, performing routine re-qualifications, maintaining the site validation master plan, troubleshooting problems related to GxP operations, accessing the impact of change to qualified systems and interacting with regulatory authorities during audits.
  • At a minimum, the position should be able to execute work independently, work with various groups across the organization and be able to oversee and lead projects to ensure that cGMP/GLP equipment, facilities and utilities perform as intended.
  • In addition, knowledge of electronic systems including PDOCs, LIMS, SAP, MS Word and MS Excel is required as part of the job. 

ROLE RESPONSIBILITIES

Lead validation activities for capital and non-capital projects, including:

  • Validation master planning
  • Generation of qualification/verification protocols
  • Execution of qualification/verification protocols
  • Final Report writing for qualification/verification protocols
  • Supervision and direction of others performing this work
  • Perform routine re-qualification activities Maintain Site Validation Master Plan Support regulatory audits through the preparation, defense and interaction with auditors in areas related to equipment, instrumentation, facilities and utilities
  • Provide expertise for trouble-shooting and resolution of issues related to equipment, instrumentation, facilities and utilities Assess potential impact of changes to qualified systems  
  • Identify and implement validation best practices to continuously improve the site validation program Represent engineering validation on site or network teams as necessary
  • The position requires execution and management of multiple projects at the same time and good communication skills to keep customers, peers, and area management up-to-date with progress of all projects in order to ensure validations are completed in a timely manner and on schedule.

BASIC QUALIFICATIONS

  • A minimum 7 years of experience and a Bachelor's degree in any of the following disciplines:  Biochemistry, Biotechnology, Chemical Engineering, Chemistry, or equivalent science related or engineering discipline is required
    OR
  • A minimum of 4 years of experience and a Master's in any of the following disciplines:  Biochemistry, Biotechnology, Chemical Engineering, Chemistry, or equivalent science related or engineering discipline is required.
     

PREFERRED QUALIFICATIONS

  • Direct knowledge and experience in equipment/utility qualification or verification within a biopharmaceutical or pharmaceutical cGMP environment is preferred.
  • Experience with FDA and EU licensing and inspection is preferred.
  • Experience with project management is preferred. 
  • Additional experience in other areas of validation, particularly verification, is preferred.

PHYSICAL/MENTAL REQUIREMENTS

  • Position requirements are typical for an office-based work environment with some shop floor exposure.  There are no unusual physical or mental requirements for this position.
     

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Schedule is primarily day shift but may require off-shift work on occasions.  The position may require working on the floor in manufacturing areas at times which will require a focus on safety. Aseptic gowning could be required. 

Other Job Details:

  • Last Date to Apply: August 11th, 2021

  • Eligible for Employee Referral Bonus

  • Eligible for Relocation Assistance

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.

Quality Assurance and Control

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