Senior Cleaning Validation Engineer

SUMMARY:

Responsible for administration of the cleaning validation program.  Responsibilities extend to oversight of environmental monitoring programs, and plant cleaning and sanitation practices.  Maintain ongoing communication with internal Operations, Sales, Quality Assurance, external laboratories and customers regarding cleaning validation projects and environmental monitoring activities.

Scope of the position includes all Sharp US commercial locations.  The position will be located at a designated site.  Travel to multiple sites is required

Duties include:

• Development and assessment of cleaning procedures and matrices for products and equipment trains.
• Development of cleaning validation approaches, generation and execution of protocols and closure of reports.
• Administration of environmental monitoring program for air and water quality.

Requisite abilities and skills include:

• 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

The following duties are included but not limited to:

• 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.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

SUPERVISORY RESPONSIBILITIES:

Provide guidance and support to project team members.  Coach, train and supervise junior team members in the execution of validation protocols, cleaning procedures and environmental monitoring as necessary. Oversee project team members and support Validation staff in the development and execution of protocols and reports. Review executed protocols for conformance with requirements and good cleaning validation practices.

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:

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
• 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.

MATHEMATICAL SKILLS:

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. 

LANGUAGE SKILLS:

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 the following groups:

• Internal: Frequent contact with the Quality Department, and Operations employees for information exchange, collaboration, problem solving, direction regarding customer validation issues. Frequent contact with Account Executives for information exchange and direction regarding customer validation issues. 
• External: Frequent contact with customer representatives conducting audits, planning new product introductions, and problem-solving validation issues. Occasional contact with regulatory representatives (e.g. FDA) for inspections, questions and problem resolution related to cleaning and sanitation.  Frequent contact with contract laboratories. 

Office Skills:

• Ability to work with independent responsibility in a team environment. 
• Ability to communicate effectively, both orally and in writing.  Requires excellent written communication skills. 
• Must be proficient in the use of Microsoft Office.
• Must be proficient in the use of Microsoft Excel.
• Ability to plan and schedule validation activities.
• Good oral communication, organizational and planning skills.
• Influencing non-direct reporting staff to complete activities according to established plans.

REASONING ABILITY:

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.

CERTIFICATES, LICENSES, REGISTRATIONS:

ASQ certification is beneficial

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use hands.  The employee frequently is required to sit.  The employee is occasionally required to stand, walk, and reach with hands and arms.  The employee must occasionally lift and/or move up to 20 pounds.  Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is normally required to sit at a desk and periodically go onto the shop floor.  The working environment is clean and not normally subject to hazardous environment or conditions.

Approximately 50 percent auto travel between local sites.

Travel to customers and laboratories as required.  Ability to travel internationally.

DISCLAIMER:

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.