- 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.
- 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
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Cleaning Validation Specialist - Bangor, United States - BioSpectra
1 week ago
Description
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.
Essential Duties and Responsibilities:
Qualifications:
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.
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