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Cleaning Validation Sr. Associate

Employer
Pfizer
Location
Sanford, North Carolina
Start date
May 27, 2022

View more

Discipline
Engineering, Validation Engineer
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Bio NC, Best Places to Work

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 cleaning validation and troubleshooting support for all equipment/unit operations and processes on site related to our vaccine and gene therapy programs.

Responsible for participating in the execution of cleaning validations as well as related activities and projects including continued process verification. This includes generation of protocols and cleaning assessments, direct sampling of equipment, working with manufacturing to align sample schedules, understanding Delta V controls, and pulling data from LIMs. Direct interaction with regulatory authorities during audits.

At a minimum, the person should be able to independently execute work, interact with various groups across the organization, be a self-starter, and be able to oversee and lead projects to ensure that the cleaning and/or process is running as intended, that the cleaning/process is appropriately validated and runs continuously in a validated state, and look to identify continuous improvement opportunities.

Knowledge of electronic systems including PDOC’s, LIMS, SAP, MS Word and MS Excel will be required as part of the job. The person should be highly motivated, a self-starter, and be able to work with a team on projects as well as on their own.

Role Responsibilities

Responsibilities include the following activities:

Cleaning validation activities including continued process verification related to the technology transfer of new products to the site as well as updates/optimizations of existing commercial products. This includes:

  • Generating and executing protocols and writing final reports

  • Sampling and execution

  • Generating regulatory submission documents

  • Project management of individual PV/CV activities. Assist in writing impact assessments for investigations. Participate in gap analyses and risk assessments for tech transfers

  • Assist in writing justifications for the assessment of change controls for process impact.

  • Ability to manage multiple activities of moderate complexity simultaneously. Liaise with site functions such as Manufacturing, Planning, QA, QC, Operations, and Regulatory Affairs as well as off-site functions such as PharmSci/Research and Development.

  • Support regulatory inspections through the preparation, defense and interaction with auditors in areas related to process and cleaning validation.

  • Work to implement a culture of right-first-time and continuous improvement relative to process and cleaning procedures and systems.

The position requires execution 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.

QUALIFICATIONS

  • A minimum of a BS degree in any of the following disciplines: Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, or equivalent science related field or engineering discipline.

  • 4 to 7 years of experience; or equivalent combination of education and experience is required for this position.

  • Direct knowledge and experience in process and/or cleaning validation within a biopharmaceutical/pharmaceutical cGMP environment is desired.

  • Experience with FDA and EU licensing and inspection, experience with Technology Transfer and Project Management is also required.

  • Additional experience in other areas of validation is a plus.

PHYSICAL/MENTAL REQUIREMENTS

Position requirements are typical for an office-based work environment. There are no unusual requirements for this position

Other Job Details

  • Last Date to Apply for Job: June 10th, 2022

  • Eligible for Relocation Package: YES

  • Work Location Assignment:On Premise

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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