Validation Engineer II
Reporting to the Validation Section Manager, the Validation Engineer II 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
The Validation Engineer II is expected to become a subject matter expert (SME) in Validation, provide technical expertise and guidance to management and cross functions. The Validation Engineer will assist 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. The Validation Engineer II is expected to work independently with minimal guidance of a Validation Section Manager or Sr. Validation Engineer.
The Validation Engineer is primarily responsible for executing multiple projects, on both a large and small scale by performing the following:
- Support 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.
- Oversee/Assist other Validation Engineers and/or Technicians and/or contractors with their assigned projects.
- Work independently with minimal guidance of a Validation Section Manager or Sr. Validation Engineer.
- Supports activities during regulatory audits under the direction of a Validation Section Manager or Sr. Validation Engineer.
- Demonstrate 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.
- 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.
- 2-4 years’ experience in a current Good Manufacturing Practice (cGMP) environment.
- Ability to work independently with limited managerial oversight
- Bachelor’s degree in Engineering, Science, or related
- Good written and oral communication skills
- 1-2 years of direct validation experience preferred
- 1-2 years of prior primary packaging and or secondary packaging experience
- Working Knowledge of cGMPs, International Society for Pharmaceutical Engineering (ISPE) guidelines, Data Integrity, 21 Code of Federal Regulations (CFR) Part 11 and Annex 11 regulations (Electronic Records and Electronic Signatures), industry good practices for Installation Qualification/Operational Qualification/Performance Qualification and Standard Operating Procedures.
- 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 and ability to work remotely when necessary
- 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: October 31, 2021
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