Pfizer Validation Engineer I in McPherson, Kansas
Reporting to the Validation Section Manager, the Validation Engineer will assure that equipment, facilities, and utilities are validated in accordance with cGMP principles, regulatory requirements, and company policies and standards.
The 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 Validation Engineer will manage the validation of new systems, as well as changes to existing systems, and will work closely with cross functions (laboratory, production, engineering, automation, quality, and BT) to ensure that requirements are met.
This role is particularly for airflow visualization (crew director).
The Crew Director will report to Validations Section Manager and execute activities required for the Validations Department to meet their deliverables. They will be aseptically trained and qualified and be responsible for conducting smoke studies and compiling footage to be used in smoke studies within and without an aseptic environment. When smoke studies are required for Remediation activities the Remediation activities will take precedence over other work. Activities may include actions required within the aseptic core for both the Validations and Remediation groups.
The Validation Engineer is primarily responsible for executing multiple projects, on both a large and small scale by performing the following:
Coordinate/oversee the development of new processes or troubleshoot existing ones.
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.
Executes equipment, facility, utility and computer system, Automated Process Control validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report.
Oversee and assist Engineers and/or Technicians with their assigned projects.
Participates in presentation of results to Regulatory Agency when necessary.
Provide technical expertise to define approaches and execution of 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.
Thorough understanding of risk based validation for computerized systems, industry standards and best practices for computer system validation, such as, but not limited to GAMP 5 and ASTM E2500
Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
Acquire aseptic qualifications and training required to enter the aseptic core and conduct smoke study trials suitable for review to evaluate aseptic processes and techniques per site PQPs.
Provide direction to the Aseptic Direction to achieve quality smoke study footage. Will serve as the crew lead during smoke studies and will prepare footage for evaluation.
Support project objectives through document reviews, training course development, and hands on training.
Coordinate and communicate progress on scheduled projects.
Manages own time to meet defined objectives
Bachelor's degree in Engineering, Science, or related field
1-2 years experience in a cGMP environment
Strong understanding of GMPs, Data Integrity, 21 CFR Part 11 and Annex 11 regulations (Electronic Records and Electronic Signatures), guidance for IQ/OQ/PQ and Standard Operating Procedures
Ability to work independently with limited managerial oversight
Good written and oral communication skills
Preferred Requirements :
- Validation experience
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)
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.
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.
Last Date to Apply: May 9, 2018
RELOCATION WILL BE PROVIDED
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.