Job Description

ROLE SUMMARY

Reporting to the Validation Section Manager, the Senior Validation Engineer will assure that equipment, computer systems such as vision systems, and/or manufacturing processes are validated in accordance with cGMP principles, regulatory requirements, and company policies and standards. This role will require the ability to lead and manage contract resources. Successful individuals in this role will be leaders in the department. The Engineer will on occasion be required to manage less experienced engineers and technicians. It is expected that this Engineer will mentor and lead less experienced engineers and technicians.

The Senior Validation Engineer will be required to become a subject matter expert (SME) in Validation, provide technical expertise and guidance to management and cross functions. The Senior Validation Engineer will be required to defend their area of expertise in regulatory and customer audits. The Validation Engineer will manage the validation of new systems/products/process, as well as changes to existing systems/products/processes, and will work closely with cross functions (laboratory, production, engineering, automation, quality, and BT) to ensure that requirements are met.

ROLE RESPONSIBILITIES

The Senior Validation Engineer is primarily responsible for executing multiple projects, on both a large and small scale by performing the following:

* Coordinate/oversee/manage the development of new processes or troubleshoot existing ones.
* Author, execute, or review Validation documents such as:Validation Project Plans, Validation Project Plan Reports, Validation Qualification Reports, Validation Qualification Protocols, Risk Management tools, Cleaning Calculations, Formulation Evaluations, and Deviation Handling.
* Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
* Coordinates and communicates all testing with affected functional groups and evaluates test results.
* Oversees and assist Engineers and/or Technicians with their assigned projects.
* Manages and leads contract resources on their assigned projects.
* Mentor and lead less experienced departmental members.
* Presents area of expertise in Regulatory Agency when necessary.
* Act as area SME and provide technical expertise to define approaches and execution of applicable system validation activities in accordance with cGMP, cGXP, CFR 21 Parts, 11, 210 and 211, EU Annex 11, ICH Q7, Q8 and Q9, and other applicable regulations, procedures and industry guidance.
* Participate and/or own Pfizer Quality Standard (PQS) CAS Report(s) and responses related to their area of expertise.
* Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems, processes, or equipment.
* Perform job responsibilities in compliance with cGMP, regulatory requirements, company policies and standards.

QUALIFICATIONs

Basic Qualifications:

* 5+ year experience in a cGMP environment
* Strong understanding of cGMPs, ISPE, Data Integrity, 21 CFR Part 11 and Annex 11 regulations (Electronic Records and Electronic Signatures), industry good practices for IQ/OQ/PQ and Standard Operating Procedures
* Ability to work independently with limited managerial oversight
* Bachelors degree in Engineering, Science, or related field
* Good written and oral communication skills

Preferred Qualifications:

* 7+ year experience in a cGMP environment
* 2-3 years of Inspection and/or Secondary Packaging experience preferred
* Prior experience working with assessing/qualifying/testing secondary packaging and vision systems

PHYSICAL/MENTAL REQUIREMENTS

* Requires routine sitting, standing, walking, listening and talking
* Acute mental and visual attention at all times
* Handle multiple projects while managing frequent interruptions
* Requires moderate lifting or moving up to 25 pounds (lbs)

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

* Requires regular onsite attendance
* Must have the ability to work effectively under strict deadlines
* Must be able and willing to work beyond office hours which may include weekends and holidays
* Must be capable of supporting up to 10% travel (domestic and international)

Last date to apply for job: March 23, 2021

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 providers 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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