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Sharp Services · 11 hours ago

Senior Cleaning Validation Engineer

Allentown

Full-time

Onsite

Senior Level

6+ years exp

Sharp Corporation is seeking a Senior Cleaning Validation Engineer responsible for the administration of the cleaning validation program and oversight of environmental monitoring programs. The role involves maintaining communication with internal and external stakeholders regarding cleaning validation projects and requires travel to multiple sites.

Health CareLife Science

Responsibilities

Support the cleaning validation program by contributing to development of validation approaches, strategies and executions

Assess new products and equipment against the existing cleaning matrix and standard

Develop, execute, review and approve of cleaning validation protocols and reports following industry guidelines

Participate in and support investigations related to cleaning validation studies, microbial studies, air and water sampling studies

Prepare Cleaning Validation Assessments

Review and approval of all Product Safety and Quality Assessment forms for products under consideration for packaging

Providing technical assessments for non-conformances and change controls

Responsible for communicating validation requirements with customers

Develop cleaning procedures and write SOPs

Participate in customer and regulatory audits specific to cleaning practices, validation activity and environmental monitoring at all Sharp facilities

Responsible for supervising the execution of validation activities at Sharp facilities including but not limited to cleaning, HVAC, and water sampling

Other tasks may be assigned as necessary

Qualification

Cleaning validationAnalytical method validationMicrobiological control practicesFDA regulationsCGMPsGLPsValidation protocolsPlanning skillsMicrosoft Office proficiencyMicrosoft Excel proficiencyWritten communicationOral communicationOrganizational skillsTeam collaborationProblem-solving skillsNegotiation skills

Required

Bachelor's degree (BS/BA) in scientific or technical discipline from a four-year college or university preferred with six to ten years related experience and/or training; or equivalent combination of education and experience

Knowledge and/or experience with cleaning validation for multi-use equipment

Knowledge of analytical method validation and laboratory procedures

Understanding sanitation and microbiological control practices

Ability to independently plan and schedule validation activities is required

Ability to multi-task while maintaining quality-minded results is required

Ability to commit to and meet project deadlines is required

Ability to structure validation protocols in conformance with a planned validation approach is required

Excellent written communication skills are required

Good oral communication, organizational and planning skills are required

Ability to perform mathematical operations required for cleaning validation, such as calculation acceptable residue limits, balancing of equations and unit of measure conversions

Ability to read, analyze, and interpret common scientific data and technical documents

Ability to work with independent responsibility in a team environment

Must be proficient in the use of Microsoft Office

Must be proficient in the use of Microsoft Excel

Good organizational skills are necessary

Good mental skills for analysis and problem solving are needed

Preferred

Independent certification of advanced quality skills and practices (i.e. ASQ, CQE, Six Sigma, etc.) is preferred

Knowledge of cleaning validation techniques and practices, microbiological testing and analytical method validation, and investigation of atypical test results

Knowledge of current validation and industry practices, including FDA regulations, CGMPs and GLPs, and validation guidance documents

Experience with various cleaning processes including manual cleaning, sampling, CIP, COP

ASQ certification is beneficial