Job Title:

Process Cleaning Validation Manager

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 facilities