|Job Title:||Validation Specialist|
|Post Date:||Sep 27 2013|
Minimum of a Bachelors degree in mechanical engineering, or related field.
Minimum of two years of experience in a sterile and non-sterile pharmaceutical GMP environment, in one or more of the following disciplines: Equipment Qualification, Process/Product Engineering, or Technical Services
Hands-on experience in qualifying PLCs and SCADA systems is essential.
Must possess a solid understanding of FDA Validation guidelines and industry best practice for this field; and be able to implement Validation standards on a daily basis.
Excellent planning, organizational, project management, and people skills.
Thorough knowledge of Microsoft Office Suite and statistical analysis to trend and interpret data in a sound fashion.
Must have strong verbal and written English skills; and willing to follow supervisory directions.
|Detailed Job Description:
Work with the R&D, Technical Services, Production, Maintenance, Quality, and Compliance departments to ensure that all required pre-requisite documentation is appropriately developed to support equipment, process, cleaning, and computer systems qualification activities.
Write and execute qualification protocols in a timely manner for the above.
Collect and analyze qualification data and prepare final reports for approval by management.
Coordinate and assist in commissioning and qualification activities by outside vendors and/or contractors.
Participate in audits and follow up on corrective actions relating to Validation.
Provide technical assistance to R&D, Compliance, Production, Maintenance, and Quality departments to ensure compliance with internal policies and procedures, current industry standards, cGMPs and current regulatory requirements.
Maintain up-to-date knowledge of cGMP regulatory issues particularly pertaining to Validation and ensure that company Validation policies and procedures are current.
Provide technical input on system specifications, procurement, ongoing qualification, and change control activities.
Perform other dues (such as continuously update the Validation project database, write SOPs, and review engineering drawings) as directed by the Sr. Director of Validation and Technical Services.
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