Process Cleaning Validation Manager

**Process Cleaning Validation Manager****Job Title:****Reports To:**Director of Quality Assurance**Direct Reports:**N/A**Emergency / Absentee Backup:**Director of Quality Assurance**Job Summary:**The Process Cleaning Validation Manager is responsible for all aspects of Cleaning development and Validation from start to finish, including establishing, managing, and maintaining a scientifically sound cleaning validation program. The Process Cleaning Validation Manager is responsible for the Bangor and Stroudsburg sites.**Essential Duties and Responsibilities:*** Write, review and/or revise 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 the Director of QA.**Qualifications:*** Four-year degree in Science, Engineering or related field* Five 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* Confidentiality**Physical Requirements:*** Lift up to 20 lbs. occasionally* Prolonged periods sitting at a desk and working on a computer* Ability to see and distinguish color* Bend, stoop, and carry* Repeating motion that may include wrists, hands, and fingers**Work Hours & Schedule:*** Exempt Position* Minimum of 40-45 Hours Week, or other agreed upon documented schedule* Ability and willingness to work from all BioSpectra facilitiesPrimary 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.