Cleaning Validation Specialist
Cleaning Validation Specialist Process / Cleaning Validation Supervisor Process / Cleaning Validation Manager Job Title:
Reports To:
Direct Reports:
N/A Emergency / Absentee Backup:
Job
Summary:
The Cleaning Validation Specialist is responsible for all aspects of Process Cleaning Development and Process Cleaning Validation from start to finish, including establishing, managing, and maintaining a scientifically sound cleaning validation program.
The Cleaning Validation Specialist is responsible for the Bangor and Stroudsburg sites.
Essential Duties and
Responsibilities:
Write, review and/or revise Process Cleaning Validation Master Plans.
Lead and perform risk assessments for determination of most critical cleaning conditions and acceptance criteria.
Write, review and execute cleaning related method validations including specific and non-specific analytical methods, extraction studies, and recovery studies.
Write, review and execute cleaning development protocols including lab scale coupon studies, full scale spray coverage testing, and full scale cleaning recipe and procedure development.
Responsible for development final reports summarizing development data and risk assessments for determination of cleaning matrix, family approach, and critical cleaning parameters for validation.
Write, review and execute cleaning validation protocols for product manufacturing and support processes, including analysis and review of test data results.
Responsible for summarizing results and conclusions when writing final reports.
Ensure final reports and study data is reviewed and approved in a timely manner after execution is completed.
Responsible for developing and managing the cleaning monitoring program including discrepancy investigations and periodic reports.
Perform sampling for cleaning studies including collection of rinse water sampling and surface swab sampling and the submission of samples to QC lab for testing.
Coordinate and schedule cleaning development, validation and, continuous monitoring/verification activities with appropriate departments.
Lead the investigation of deviations encountered during the execution of validation and/or continuous monitoring/verification activities and provide documentation to support the findings of the investigation.
Responsible for overall supervision and oversight during execution of validation activities.
Write and provide training on SOPs relevant to cleaning validation procedures.
Evaluate cleaning procedures and revise with process improvements as necessary.
Train other personnel on rinse sampling and surface swab sampling.
Review technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, as they relate to validation and regulatory compliance issues.
Knowledgeable of current FDA guidelines and industry standards pertaining to cleaning validation.
Other duties may be assigned as deemed appropriate by management.
Qualifications:
Four year degree in Science, Engineering or related field Greater than two years of experience in cleaning validation with knowledge of current best practices Has knowledge and understanding of cGMP & ICH Q7 Have excellent analytical skills with systematic approaches to problem solving Must have experience in the principles and approaches of product/equipment cleaning validation Ability to communicate effectively at all levels in verbal and written form, including technical/business writing Organized, Thorough, Neat Must be able to read, write, speak, and understand English Must be able to distinguish color and color change Must be able to lift, reach, carry, stand, sit, and bend throughout shift Confidentiality Working Conditions:
The noise level in the work environment is usually moderate.
Reports to & Reviewed by:
The Cleaning Validation Specialist will have his/her job performance reviewed at least once per calendar year by the Associate Director of Manufacturing.
Work Hours:
The Cleaning Validation Specialist will be required to work 40 hours per week and is a salaried position.
Extenuating circumstances may require additional time for certain periods.
It is widely assumed that displacement of hours and/or days will occur on recurring and non-patterned basis.
All BioSpectra job functions require the ability and willingness to work from all BioSpectra facilities and properties.
Primary
Responsibilities:
Tasks You Excel In:
Tasks You Least Prefer:
Primary
Responsibilities:
Tasks You Excel In:
Tasks You Least Prefer:
Primary
Responsibilities:
Tasks You Excel In:
Tasks You Least Prefer:
List all applicable education.
Recommended Skills Analytical Business Correspondence Change Control Communication Confidentiality Engineering Estimated Salary: $20 to $28 per hour based on qualifications.
Reports To:
Direct Reports:
N/A Emergency / Absentee Backup:
Job
Summary:
The Cleaning Validation Specialist is responsible for all aspects of Process Cleaning Development and Process Cleaning Validation from start to finish, including establishing, managing, and maintaining a scientifically sound cleaning validation program.
The Cleaning Validation Specialist is responsible for the Bangor and Stroudsburg sites.
Essential Duties and
Responsibilities:
Write, review and/or revise Process Cleaning Validation Master Plans.
Lead and perform risk assessments for determination of most critical cleaning conditions and acceptance criteria.
Write, review and execute cleaning related method validations including specific and non-specific analytical methods, extraction studies, and recovery studies.
Write, review and execute cleaning development protocols including lab scale coupon studies, full scale spray coverage testing, and full scale cleaning recipe and procedure development.
Responsible for development final reports summarizing development data and risk assessments for determination of cleaning matrix, family approach, and critical cleaning parameters for validation.
Write, review and execute cleaning validation protocols for product manufacturing and support processes, including analysis and review of test data results.
Responsible for summarizing results and conclusions when writing final reports.
Ensure final reports and study data is reviewed and approved in a timely manner after execution is completed.
Responsible for developing and managing the cleaning monitoring program including discrepancy investigations and periodic reports.
Perform sampling for cleaning studies including collection of rinse water sampling and surface swab sampling and the submission of samples to QC lab for testing.
Coordinate and schedule cleaning development, validation and, continuous monitoring/verification activities with appropriate departments.
Lead the investigation of deviations encountered during the execution of validation and/or continuous monitoring/verification activities and provide documentation to support the findings of the investigation.
Responsible for overall supervision and oversight during execution of validation activities.
Write and provide training on SOPs relevant to cleaning validation procedures.
Evaluate cleaning procedures and revise with process improvements as necessary.
Train other personnel on rinse sampling and surface swab sampling.
Review technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, as they relate to validation and regulatory compliance issues.
Knowledgeable of current FDA guidelines and industry standards pertaining to cleaning validation.
Other duties may be assigned as deemed appropriate by management.
Qualifications:
Four year degree in Science, Engineering or related field Greater than two years of experience in cleaning validation with knowledge of current best practices Has knowledge and understanding of cGMP & ICH Q7 Have excellent analytical skills with systematic approaches to problem solving Must have experience in the principles and approaches of product/equipment cleaning validation Ability to communicate effectively at all levels in verbal and written form, including technical/business writing Organized, Thorough, Neat Must be able to read, write, speak, and understand English Must be able to distinguish color and color change Must be able to lift, reach, carry, stand, sit, and bend throughout shift Confidentiality Working Conditions:
The noise level in the work environment is usually moderate.
Reports to & Reviewed by:
The Cleaning Validation Specialist will have his/her job performance reviewed at least once per calendar year by the Associate Director of Manufacturing.
Work Hours:
The Cleaning Validation Specialist will be required to work 40 hours per week and is a salaried position.
Extenuating circumstances may require additional time for certain periods.
It is widely assumed that displacement of hours and/or days will occur on recurring and non-patterned basis.
All BioSpectra job functions require the ability and willingness to work from all BioSpectra facilities and properties.
Primary
Responsibilities:
Tasks You Excel In:
Tasks You Least Prefer:
Primary
Responsibilities:
Tasks You Excel In:
Tasks You Least Prefer:
Primary
Responsibilities:
Tasks You Excel In:
Tasks You Least Prefer:
List all applicable education.
Recommended Skills Analytical Business Correspondence Change Control Communication Confidentiality Engineering Estimated Salary: $20 to $28 per hour based on qualifications.
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