Associate Validation Engineer
About The Position
The Validation Engineer I provides support in performing equipment, facility and utility qualification activity and re-qualification activity to ensure compliance to cGMP and Amneal's quality requirements. Essential Functions: Assist in the preparation/ execution of Installation Qualification(IQ)/Operational Qualification(OQ)/ Performance Qualification(PQ) protocols for equipment, facility and utilities as well as related software. Help generate qualification report and help summarize the results which will be reviewed by the supervisor Performs re-qualification of equipment, facility and utilities as required under supervision Identify deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution Draft Standard Operating Procedure(SOP) for new operational equipment Supports process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges and challenge tests criteria to technical service Works with equipment vendors to collect equipment manual and other required documents Closely works with the maintenance & facility teams to complete new equipment installation as per project requirement. Additional Responsibilities: Assist with engineering projects and performs other duties as assigned.
Requirements
- Bachelors Degree (BA/BS) Degree in Pharmaceutical manufacturing, Engineering, Science or relevant field
- 0-2 years of experience in Engineering, Pharmaceutical Industry, cGMP environment with Bachelor degree.
- 1 year or more in Experience in Engineering, Pharmaceutical Industry, cGMP environment with Bachelor degree.
- Proficient in MS Office.
- Excellent technical writing skills.
- Excellent oral and written communication skills.
- Must be able for follow direction and execute assigned work independently, after initial training is completed.
- Ability to work both independently and in conjunction with a team
Responsibilities
- Assist in the preparation/ execution of Installation Qualification(IQ)/Operational Qualification(OQ)/ Performance Qualification(PQ) protocols for equipment, facility and utilities as well as related software.
- Help generate qualification report and help summarize the results which will be reviewed by the supervisor
- Performs re-qualification of equipment, facility and utilities as required under supervision
- Identify deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution
- Draft Standard Operating Procedure(SOP) for new operational equipment
- Supports process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges and challenge tests criteria to technical service
- Works with equipment vendors to collect equipment manual and other required documents
- Closely works with the maintenance & facility teams to complete new equipment installation as per project requirement.
- Assist with engineering projects and performs other duties as assigned.
Benefits
- Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months.
- At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs.
- This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement.
- We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
