What are the responsibilities and job description for the Associate Validation Engineer position at Amneal?
Description:
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.
Qualifications:
Education:
- Bachelors Degree (BA/BS) Degree in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required
Experience:
- less than one year in 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.
Skills:
- Proficient in MS Office. - Advanced
- Excellent technical writing skills. - Intermediate
- Excellent oral and written communication skills. - Intermediate
- Must be able for follow direction and execute assigned work independently, after initial training is completed. - Intermediate
- Ability to work both independently and in conjunction with a team - Advanced
