Engineering Validation Senior Associate

Employer
Pfizer
Location
Sanford, North Carolina
Posted
Jun 21, 2022
Ref
4857687
Required Education
Bachelors Degree
Position Type
Full time

Why Patients Need You

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.

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

Responsibilities include the following:

  • 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.

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

Qualifications

  • A minimum of an AAS degree + 7 years of experience; BS + 4 years of experience; or MS +2 years of experience in any of the following disciplines: Biochemistry, Biotechnology, Chemical Engineering, Chemistry, or equivalent science related or engineering discipline.

  • Direct knowledge and experience in equipment/utility qualification or verification within a biopharmaceutical or pharmaceutical cGMP environment is desired.

  • 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 a plus.

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.


Work Location Assignment:On Premise

Other Job Details:

  • Last Date to Apply for Job: July 5th, 2022

  • Relocation Assistance Eligible

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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

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