Requisition ID 15335BR
Title Sr. Validation Area Spec-Proj- Cart Exp
Job Category Validation
Job Description Position Purpose:
Primary responsibility is to provide/lead validation services required for the successful delivery of the LF36 project, including:
Provide validation and technical support through the preparation, execution, data analysis, and report writing for IQ, OQ and PQ protocols.
Ownership of Change Requests (CR’s) related to project validation responsibilities.
Perform compliance and technical reviews/approvals of protocols and protocol data.
Create new and modify existing validation procedures as required.
Lead validation failure investigations and non-conformities utilizing root cause analysis techniques.
Create and modify existing configuration item lists (CIL’s) as required.
Review and approve specifications, procedures, and other required supporting documents to maintain the validated state of equipment and processes.
Participate in FAT, SAT, commissioning efforts for equipment, automation systems and processes and successfully transition into the ownership role for validation efforts related to the equipment, system or process.
Identify process improvements before equipment, systems or processes are placed under change control during validation.
Education: BS in Engineering, Computer Science, or applicable technical degree
Experience: Minimum 7 years validation or quality related discipline experience in pharmaceutical environment. Minimum of 1 year of project management experience for small to medium sized projects with experience developing project schedules and tracking performance. At least 2 years of demonstrated experience using root-cause analysis techniques to solve problems.
Technical/Process/Functional Knowledge: Knowledgeable in the following areas: Expert in quality concepts including technical and compliance review of documents, expert competence in one or more core validation areas (sterilization, packaging, cleaning, utilities, process or computer validation). Expert in cGMP documentation practices. Requires a minimum of 2 years of experience in reviewing GMP documents for compliance purposes for approval of quality documentation. Basic computer skills including experience in the use of Microsoft word, Excel, etc. Ability to independently write protocols and technical documents without supervision. Knowledge of statistical methods. Expert knowledge of cGMP documentation practices required. Excellent oral and written communication skills. Experience in regulatory cGMP regulations. Experience in validation test equipment including temperature mapping equipment, Kaye equipment as an example, desired. Expert knowledge in being a project team participant and team leader. Expert in utilizing appropriate root-cause analysis tools and techniques.
Physical Requirements:
Ability to lift up to 40 lbs. with assistance.
Ability to work in confined spaces and near operating equipment.
Ability to be clean room certified. Ability to work in loud noise environments.
Ability to work hours necessary to support production and /or maintenance activities.
Department Project - Cart. Expan
Position Location US - Clayton, NC
City clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Title Sr. Validation Area Spec-Proj- Cart Exp
Job Category Validation
Job Description Position Purpose:
Primary responsibility is to provide/lead validation services required for the successful delivery of the LF36 project, including:
Provide validation and technical support through the preparation, execution, data analysis, and report writing for IQ, OQ and PQ protocols.
Ownership of Change Requests (CR’s) related to project validation responsibilities.
Perform compliance and technical reviews/approvals of protocols and protocol data.
Create new and modify existing validation procedures as required.
Lead validation failure investigations and non-conformities utilizing root cause analysis techniques.
Create and modify existing configuration item lists (CIL’s) as required.
Review and approve specifications, procedures, and other required supporting documents to maintain the validated state of equipment and processes.
Participate in FAT, SAT, commissioning efforts for equipment, automation systems and processes and successfully transition into the ownership role for validation efforts related to the equipment, system or process.
Identify process improvements before equipment, systems or processes are placed under change control during validation.
Education: BS in Engineering, Computer Science, or applicable technical degree
Experience: Minimum 7 years validation or quality related discipline experience in pharmaceutical environment. Minimum of 1 year of project management experience for small to medium sized projects with experience developing project schedules and tracking performance. At least 2 years of demonstrated experience using root-cause analysis techniques to solve problems.
Technical/Process/Functional Knowledge: Knowledgeable in the following areas: Expert in quality concepts including technical and compliance review of documents, expert competence in one or more core validation areas (sterilization, packaging, cleaning, utilities, process or computer validation). Expert in cGMP documentation practices. Requires a minimum of 2 years of experience in reviewing GMP documents for compliance purposes for approval of quality documentation. Basic computer skills including experience in the use of Microsoft word, Excel, etc. Ability to independently write protocols and technical documents without supervision. Knowledge of statistical methods. Expert knowledge of cGMP documentation practices required. Excellent oral and written communication skills. Experience in regulatory cGMP regulations. Experience in validation test equipment including temperature mapping equipment, Kaye equipment as an example, desired. Expert knowledge in being a project team participant and team leader. Expert in utilizing appropriate root-cause analysis tools and techniques.
Physical Requirements:
Ability to lift up to 40 lbs. with assistance.
Ability to work in confined spaces and near operating equipment.
Ability to be clean room certified. Ability to work in loud noise environments.
Ability to work hours necessary to support production and /or maintenance activities.
Department Project - Cart. Expan
Position Location US - Clayton, NC
City clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required