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Sharp Services · 10 hours ago

Senior Cleaning Validation Engineer

Allentown, PA

Full-time

Onsite

Senior Level

6+ years exp

Sharp Services is responsible for overseeing the cleaning validation program across its commercial locations. The Senior Cleaning Validation Engineer will develop and assess cleaning procedures, manage environmental monitoring programs, and ensure compliance with industry guidelines and regulations.

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

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 use scientific notation, conversion factors and basic statistics, such as mean, standard deviation, etc

Ability to use mathematical analysis for activities such as trend analysis, sampling plan calculations, ratio analysis, etc

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

Ability to read and understand technical documents and engineering drawings

Ability to respond to common inquiries from customers regarding validation issues

Ability to effectively present information to internal and external groups

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

Need an ability to negotiate to reach a common solution meeting everyone's needs

Preferred

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

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