Sr. Validation EngineerPermanent
North Carolina, Wilson - 27893Job Simplification
The announced job offer is made public by the firm: Fresenius Kabi and it was included in jobs list the date of: 2022-10-22 in the website greenenergyjobsonline.com.
It is announced that they have a job offer at the category of Engineering and the jobs location is in the state of North Carolina at the city Wilson, in the country US - at this current ZipCode: 27893
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Job Overview
POSITION SUMMARY:
Responsible for providing technical support to operations in terms of equipment/system initial validation and equipment/system requalification. Will participate in equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. Individual must also coordinate HEPA filter integrity/velocity testing and critical area airflow pattern testing. The individual must have a comprehensive understanding of cGMPs and become certified to enter controlled areas of the plant.
Provides direction through direct or indirect supervision to validation team members and contractors as necessary.
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
Schedules and participates in equipment requalifications per Standard Operating Procedures (SOPs).
Coordinates and communicates all testing with affected functional groups, where applicable, and evaluates test results.
Approves final report and/ or assembles and circulates for approval when necessary.
Executes validation studies, or acts as a Project Manager and/ or Technical Reviewer, for equipment to include protocol preparation, scheduling, protocol execution, and final report preparation.
Presents results to Regulatory Agency when necessary.
Programs, leads and/ or operates department instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
Develops/improves validation programs as needed to remain current with cGMPs and industry standards.
Schedules and executes, when applicable, HEPA Filter and critical area testing per SOP, and airflow pattern testing.
Programs, leads, and/or operates test equipment such as smoke generators, photometers, velocity meters, etc., and accurately records and evaluates results.
Represents Validation department 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)
REQUIREMENTS
B.S. degree in Engineering, Science or related area of study;
3-5 years of related experience in a cGMP facility.
Generation of reports, deviations or other technical documents.
Installation, Operational and Performance Qualification protocol generation and execution.
Job Type: Full-time
Benefits:
401(k)
401(k) matching
Dental insurance
Employee assistance program
Employee discount
Flexible schedule
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Parental leave
Professional development assistance
Referral program
Relocation assistance
Tuition reimbursement
Vision insurance
Schedule:
8 hour shift
Supplemental pay types:
Bonus pay
Signing bonus
Work Location: One location
Responsible for providing technical support to operations in terms of equipment/system initial validation and equipment/system requalification. Will participate in equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. Individual must also coordinate HEPA filter integrity/velocity testing and critical area airflow pattern testing. The individual must have a comprehensive understanding of cGMPs and become certified to enter controlled areas of the plant.
Provides direction through direct or indirect supervision to validation team members and contractors as necessary.
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
Schedules and participates in equipment requalifications per Standard Operating Procedures (SOPs).
Coordinates and communicates all testing with affected functional groups, where applicable, and evaluates test results.
Approves final report and/ or assembles and circulates for approval when necessary.
Executes validation studies, or acts as a Project Manager and/ or Technical Reviewer, for equipment to include protocol preparation, scheduling, protocol execution, and final report preparation.
Presents results to Regulatory Agency when necessary.
Programs, leads and/ or operates department instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
Develops/improves validation programs as needed to remain current with cGMPs and industry standards.
Schedules and executes, when applicable, HEPA Filter and critical area testing per SOP, and airflow pattern testing.
Programs, leads, and/or operates test equipment such as smoke generators, photometers, velocity meters, etc., and accurately records and evaluates results.
Represents Validation department 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)
REQUIREMENTS
B.S. degree in Engineering, Science or related area of study;
3-5 years of related experience in a cGMP facility.
Generation of reports, deviations or other technical documents.
Installation, Operational and Performance Qualification protocol generation and execution.
Job Type: Full-time
Benefits:
401(k)
401(k) matching
Dental insurance
Employee assistance program
Employee discount
Flexible schedule
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Parental leave
Professional development assistance
Referral program
Relocation assistance
Tuition reimbursement
Vision insurance
Schedule:
8 hour shift
Supplemental pay types:
Bonus pay
Signing bonus
Work Location: One location
Employer Overview
Fresenius Kabi
North Carolina, Wilson - 27893- Agency