Cleaning Validation Manager

**Cleaning Validation Manager ($65,000 to $85000 annual salary)****Job Title:****Reports To:**Compliance Manager**Direct Reports:**N/A**Emergency / Absentee Backup:**Compliance Manager**Job Summary:**The Cleaning Validation Manager is responsible for all aspects of Environmental Monitoring and Process Cleaning Validation from Development to equipment release, including establishing, managing, and maintaining a scientifically sound cleaning validation, verification, and compliance program. The Cleaning Validation Manager is responsible for activities at the Bangor and Stroudsburg facilities.**Essential Duties and Responsibilities:*** Responsible process room Cleaning Validation and Environmental Monitoring programs including protocol/report authoring, training, execution of cleaning validation activities and sample collection* Responsible for overall supervision and oversight during execution of cleaning validation/verification activities from process development through process campaigns.* Ensure compliance with regulatory standards and internal master plan associated with Cleaning Validation* 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* Write, review, and execute cleaning validation protocols for product manufacturing and support processes, including analysis and review of test data results* Responsible for creating final reports summarizing development data and risk assessments for determination of cleaning matrix and critical cleaning parameters for validation* Support any investigation of deviations encountered during the execution of validations and/or continuous monitoring/verification activities and provide documentation to support the findings of the investigation* Lead and perform risk assessments for determination of most critical cleaning conditions and acceptance criteria* 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* 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* Support developmental projects in relation to new cleaning equipment/process* 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 cleaning validation and regulatory compliance issues* Ensure cleaning validation and procedures are reviewed and verified to be in a state of validation on an annual basis* Responsible for evaluating environmental monitoring results and performing risk assessments on data for release* Perform and oversee spike recoveries studies on materials of construction* Consult with QC on different method of analysis for room release* Other duties may be assigned as deemed appropriate by the Compliance Manager**Qualifications:*** Four-year degree in Science, Engineering or related field* Minimum 3 years of experience in cleaning validation with knowledge of current best practices* Has knowledge and understanding of cGMP & ICH Q7, FDA guidelines and industry standards* 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* Confidentiality**Physical Requirements:*** Lift up to 15 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:*** 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.