Validation Engineer
Company Name:
Gallus BioPharmaceuticals
Job Descriptions:
JOB TITLE: Validation Engineer
REPORTS TO: Validation Supervisor
EMPLOYEE CLASSIFICATION: FT
JOB SUMMARY/OBJECTIVE:
Responsible for writing and executing validation protocols for new equipment, instruments, facilities, utilities, and computer systems as well as requalification activities. The position is also responsible for the analysis of data, investigation of protocol discrepancies and completing summary reports. Participation on various project teams will be required.
REPORTING RELATIONSHIPS: Individual Contributor
ESSENTIAL JOB FUNCTIONS:
Responsible for protocol executions, which will require interface with Manufacturing, QA, QC, Facilities, and Engineering to assure expeditious and accurate completion of validations.
Develop validation plans, protocols, and associated summary reports.
Performs requalifications to maintain the validated state of systems as defined by approved validation SOPs.
Oversight for writing and revising department SOPs as necessary to be in compliance with regulatory requirements.
Represent the Validation department on various project teams as required.
Required
Experience:
POSITION REQUIREMENTS:
Pharmaceutical/Biopharmaceutical or related industry background is required.
Strong interpersonal and communications skills; written and oral, and a demonstrated ability to make logical decisions based on guidance from management.
Demonstrated ability to work on multiple projects.
Good organizational skills and problem solving abilities.
EDUCATION AND
Qualifications:
Bachelor's Degree in Engineering, life sciences or technical disciple or equivalent experience.
2-5 years of experience in the area of equipment, instruments, facilities, utilities, or computer systems validation.
Proficient with computer (MS Office). Working knowledge of controlled documentation and data systems.
Knowledgeable of cGMP regulations.
PHYSICAL DEMANDS/FACTORS:
Ability to aseptically gown and/or sterile gown as needed
Ability to work within environmental clean rooms
Ability to function in a rapidly changing environment and balance multiple priorities simultaneously
While performing the duties of this job, the employee is required to read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
Is regularly required to talk and hear. The employee frequently is required to stand and/or walk for extended periods. The employee is also required to sit, use hands to finger, handle, or feel: reach with hands and arms: and stoop, kneel, or crouch.
Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.
Keyword: Validation Engineer
From: Gallus BioPharmaceuticalsEstimated Salary: $20 to $28 per hour based on qualifications.
Gallus BioPharmaceuticals
Job Descriptions:
JOB TITLE: Validation Engineer
REPORTS TO: Validation Supervisor
EMPLOYEE CLASSIFICATION: FT
JOB SUMMARY/OBJECTIVE:
Responsible for writing and executing validation protocols for new equipment, instruments, facilities, utilities, and computer systems as well as requalification activities. The position is also responsible for the analysis of data, investigation of protocol discrepancies and completing summary reports. Participation on various project teams will be required.
REPORTING RELATIONSHIPS: Individual Contributor
ESSENTIAL JOB FUNCTIONS:
Responsible for protocol executions, which will require interface with Manufacturing, QA, QC, Facilities, and Engineering to assure expeditious and accurate completion of validations.
Develop validation plans, protocols, and associated summary reports.
Performs requalifications to maintain the validated state of systems as defined by approved validation SOPs.
Oversight for writing and revising department SOPs as necessary to be in compliance with regulatory requirements.
Represent the Validation department on various project teams as required.
Required
Experience:
POSITION REQUIREMENTS:
Pharmaceutical/Biopharmaceutical or related industry background is required.
Strong interpersonal and communications skills; written and oral, and a demonstrated ability to make logical decisions based on guidance from management.
Demonstrated ability to work on multiple projects.
Good organizational skills and problem solving abilities.
EDUCATION AND
Qualifications:
Bachelor's Degree in Engineering, life sciences or technical disciple or equivalent experience.
2-5 years of experience in the area of equipment, instruments, facilities, utilities, or computer systems validation.
Proficient with computer (MS Office). Working knowledge of controlled documentation and data systems.
Knowledgeable of cGMP regulations.
PHYSICAL DEMANDS/FACTORS:
Ability to aseptically gown and/or sterile gown as needed
Ability to work within environmental clean rooms
Ability to function in a rapidly changing environment and balance multiple priorities simultaneously
While performing the duties of this job, the employee is required to read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
Is regularly required to talk and hear. The employee frequently is required to stand and/or walk for extended periods. The employee is also required to sit, use hands to finger, handle, or feel: reach with hands and arms: and stoop, kneel, or crouch.
Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.
Keyword: Validation Engineer
From: Gallus BioPharmaceuticalsEstimated Salary: $20 to $28 per hour based on qualifications.
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