Validation Engineer II
A$ A' A' ?POSITION SUMMARY Provide support for validations programs through the preparation and execution of equipment, instrumentation, and process validation studies in accordance with corporate policies and procedures.
Performs a variety of tasks supporting validation programs; often under deadlines by working on complex problems in which analysis of situations or data requires an in-depth evaluation of multiple factors.
The incumbent is expected to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
May act independently to determine methods and procedures on new assignments and may supervise the activities of other lower-level personnel and contractors.
DUTIES AND RESPONSIBILITIES A cents EUR cents Write validation protocols and reports in support of corporate validation program A cents EUR cents Perform validation activities described in validation protocols including thermal studies, cleaning, process, methods, equipment and utilities validation A cents EUR cents Investigate and troubleshoot problems which occur during the validation studies A cents EUR cents Prepare and review completed and executed validation packages by compiling and analyzing validation data for submittal for review and approval A cents EUR cents Maintain an up-to-date knowledge of validation requirements, practices, and procedures A cents EUR cents Work with validation and metrology contractors when required A cents EUR cents Interact with manufacturing operations and facilities / engineering departments to facilitate protocol generation and execution A cents EUR cents Write validation plans related to specific projects and facilities A cents EUR cents Conduct validation risk assessments related to specific projects and facilities A cents EUR cents Write and review validation policies and procedures A cents EUR cents Support implementation of validated system change requests and resolution of process deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval A cents EUR cents Represent and defend validation programs to client auditors and regulatory authorities A cents EUR cents Specific duties may vary depending upon departmental requirements EXPERIENCE AND QUALIFICATIONS A cents EUR cents Bachelor's degree in a scientific, engineering, or technical discipline (Master's degree preferred) A cents EUR cents Minimum 5 years of relevant industry experience (medical devices, in vitro diagnostics, pharmaceuticals, etc.
) A cents EUR cents Experience with validation standards in a GMP and ISO9001:
2000 environment preferred A cents EUR cents Six Sigma Green Belt Certification preferred A cents EUR cents ASQ Certified (CQE) is beneficial KNOWLEDGE, SKILLS AND ABILITIES A cents EUR cents Knowledge of working in a regulated environment and standard industry validation practices is required A cents EUR cents Demonstrate superior competency in analytical skills o Logical problem solving and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion A cents EUR cents Ability to coordinate and work on multiple validation projects is required A cents EUR cents Experience in working with a variety of laboratory equipment, manufacturing processes, facilities, and utilities equipment is required.
o Typical manufacturing processes include assembly, weighing, mixing, dispensing, drying and packaging A cents EUR cents Strong oral, written communication and interpersonal skills are required o Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of project data A cents EUR cents Proficiency using standard validation test instrumentation is required A cents EUR cents Proficiency with MS Office Suite (Word, Excel, Project, and PowerPoint) is required.
PHYSICAL DEMANDS This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.
WORK ENVIRONMENT This position will spend time in a Clean Room environment.
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Estimated Salary: $20 to $28 per hour based on qualifications.
Performs a variety of tasks supporting validation programs; often under deadlines by working on complex problems in which analysis of situations or data requires an in-depth evaluation of multiple factors.
The incumbent is expected to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
May act independently to determine methods and procedures on new assignments and may supervise the activities of other lower-level personnel and contractors.
DUTIES AND RESPONSIBILITIES A cents EUR cents Write validation protocols and reports in support of corporate validation program A cents EUR cents Perform validation activities described in validation protocols including thermal studies, cleaning, process, methods, equipment and utilities validation A cents EUR cents Investigate and troubleshoot problems which occur during the validation studies A cents EUR cents Prepare and review completed and executed validation packages by compiling and analyzing validation data for submittal for review and approval A cents EUR cents Maintain an up-to-date knowledge of validation requirements, practices, and procedures A cents EUR cents Work with validation and metrology contractors when required A cents EUR cents Interact with manufacturing operations and facilities / engineering departments to facilitate protocol generation and execution A cents EUR cents Write validation plans related to specific projects and facilities A cents EUR cents Conduct validation risk assessments related to specific projects and facilities A cents EUR cents Write and review validation policies and procedures A cents EUR cents Support implementation of validated system change requests and resolution of process deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval A cents EUR cents Represent and defend validation programs to client auditors and regulatory authorities A cents EUR cents Specific duties may vary depending upon departmental requirements EXPERIENCE AND QUALIFICATIONS A cents EUR cents Bachelor's degree in a scientific, engineering, or technical discipline (Master's degree preferred) A cents EUR cents Minimum 5 years of relevant industry experience (medical devices, in vitro diagnostics, pharmaceuticals, etc.
) A cents EUR cents Experience with validation standards in a GMP and ISO9001:
2000 environment preferred A cents EUR cents Six Sigma Green Belt Certification preferred A cents EUR cents ASQ Certified (CQE) is beneficial KNOWLEDGE, SKILLS AND ABILITIES A cents EUR cents Knowledge of working in a regulated environment and standard industry validation practices is required A cents EUR cents Demonstrate superior competency in analytical skills o Logical problem solving and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion A cents EUR cents Ability to coordinate and work on multiple validation projects is required A cents EUR cents Experience in working with a variety of laboratory equipment, manufacturing processes, facilities, and utilities equipment is required.
o Typical manufacturing processes include assembly, weighing, mixing, dispensing, drying and packaging A cents EUR cents Strong oral, written communication and interpersonal skills are required o Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of project data A cents EUR cents Proficiency using standard validation test instrumentation is required A cents EUR cents Proficiency with MS Office Suite (Word, Excel, Project, and PowerPoint) is required.
PHYSICAL DEMANDS This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.
WORK ENVIRONMENT This position will spend time in a Clean Room environment.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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