Validation Engineer III
JOB SUMMARYResponsible for validation deliverables for projects, as well as participation as an interactive member on Project Teams as a representative of the validation department.
Writes and executes commissioning and validation documents for equipment, instruments, facilities, utilities, and processes utilizing the life-cycle approach, in accordance with the Site Validation Master Plan, project specific Validation Plans, and departmental SOPs.
The position is also responsible for the analysis of data, completion of validation protocols, and protocol and validation plan summary reports.
Participation on various project teams will be required.
JOB DESCRIPTIONCoordinate validation activities for the Thermo Fisher Scientific Middletown, VA site.
Perform, evaluate and analyze validation protocols and associated data for compliance with FDA and ISO guidelines.
Assist with executing to the Validation Master Plan for the plant site.
Identify, schedule and perform validation studies to meet production and revalidation requirements for the plant site.
Evaluate and analyze validation data collected during projects, verify adequacy of the data and compliance with regulatory requirements.
Ensure qualification plans are in place for all Engineering projectsDetermine if external resources are required based on validation project loadTrain internal and external validation personnel in all facets of validation activitiesResponsible for the performance of all routine revalidations on schedule for the plant site, including writing protocols, performing validation runs, analyzing data, writing reports and assembling final validation packets.
Schedule validation runs to meet production and revalidation requirements.
Review protocols and studies and provide feedback to ManagerAssist Engineering Team with addressing CAPAsAct as chairperson for the site Validation Committee.
Review/revise site Validation Procedures.
Represent operations regarding validation during inspections or audits.
Prepare reports and validation summaries for work performed by those other than validation specialists.
Performs other duties as assigned.
Support cleaning validation initiatives to meet regulatory expectations and project timelines.
Minimum Requirements/QualificationsB.
S.
Degree in Engineering or scientific discipline with 5
years validation experience in the pharmaceutical or medical device industry performing the tasks listed above.
Physical RequirementsNormal office and manufacturing environment.
Position may require frequent communication and walking to other areas in which designated PPE will be required.
Position will require sitting and standing.
Employee may occasionally lift and/or move up to 10 pounds.
Non-Negotiable Hiring Criteria:
Influence and coordinate activities of personnel over which he/she has no direct authorityStrong organizational skillsWork independently with minimal supervisionEffectively communicate with all levels of the organization from the General Manager to the production operatorsMust be proficient with Microsoft OfficeTravel will be required to support multiple projects.
Estimated Salary: $20 to $28 per hour based on qualifications.
Writes and executes commissioning and validation documents for equipment, instruments, facilities, utilities, and processes utilizing the life-cycle approach, in accordance with the Site Validation Master Plan, project specific Validation Plans, and departmental SOPs.
The position is also responsible for the analysis of data, completion of validation protocols, and protocol and validation plan summary reports.
Participation on various project teams will be required.
JOB DESCRIPTIONCoordinate validation activities for the Thermo Fisher Scientific Middletown, VA site.
Perform, evaluate and analyze validation protocols and associated data for compliance with FDA and ISO guidelines.
Assist with executing to the Validation Master Plan for the plant site.
Identify, schedule and perform validation studies to meet production and revalidation requirements for the plant site.
Evaluate and analyze validation data collected during projects, verify adequacy of the data and compliance with regulatory requirements.
Ensure qualification plans are in place for all Engineering projectsDetermine if external resources are required based on validation project loadTrain internal and external validation personnel in all facets of validation activitiesResponsible for the performance of all routine revalidations on schedule for the plant site, including writing protocols, performing validation runs, analyzing data, writing reports and assembling final validation packets.
Schedule validation runs to meet production and revalidation requirements.
Review protocols and studies and provide feedback to ManagerAssist Engineering Team with addressing CAPAsAct as chairperson for the site Validation Committee.
Review/revise site Validation Procedures.
Represent operations regarding validation during inspections or audits.
Prepare reports and validation summaries for work performed by those other than validation specialists.
Performs other duties as assigned.
Support cleaning validation initiatives to meet regulatory expectations and project timelines.
Minimum Requirements/QualificationsB.
S.
Degree in Engineering or scientific discipline with 5
years validation experience in the pharmaceutical or medical device industry performing the tasks listed above.
Physical RequirementsNormal office and manufacturing environment.
Position may require frequent communication and walking to other areas in which designated PPE will be required.
Position will require sitting and standing.
Employee may occasionally lift and/or move up to 10 pounds.
Non-Negotiable Hiring Criteria:
Influence and coordinate activities of personnel over which he/she has no direct authorityStrong organizational skillsWork independently with minimal supervisionEffectively communicate with all levels of the organization from the General Manager to the production operatorsMust be proficient with Microsoft OfficeTravel will be required to support multiple projects.
Estimated Salary: $20 to $28 per hour based on qualifications.
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