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:

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* Tasks You Least Prefer:

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* List all applicable education.