Cleaning Validation Engineer

POSITION DESCRIPTION

Position Title: Cleaning Validation Engineer

Department: Validation

Reports To: Head of Engineering

Work Location: Decatur Illinois

Position Summary:

• The successful candidate is an SME in cleaning and sanitization effectiveness validation and has knowledge of equipment and process validation. The Engineer prepares product contact surface cleaning and room and equipment sanitization effectiveness validation process and equipment validation protocols protocol final reports and procedural documentation.

• Responsibilities include coordinating validation activities with departments and personnel and maintaining the cleaning validation processes and procedures.

• As the cleaning validation SME the candidate is knowledgeable in cleaning validation concepts practices procedures and leads and instructs others supporting cleaning validation deliverables.

Essential Duties & Responsibilities:

• Cleaning Validation Responsibilities Writing and reviewing cleaning and sanitization procedures and maintaining the Cleaning Validation Master Plan.

• Execution of cleaning validation protocol activities and sample collection.

• Responsible for adherence to FDA guidance and regulatory requirements and Rising Pharma Validation Master Plans.

• Preparing reviewing and executing related validation studies such as extraction and recovery studies for product contact surfaces and equipment surfaces.

• Preparing and executing cleaning development protocols including lab scale full scale spray coverage testing and fullscale cleaning recipe and procedure development.

• Preparing risk assessment and reports summarizing data and determination of cleaning matrix and critical cleaning parameters for validation. Assess new products being introduced to the site for alignment within the approved cleaning matrix.

• Assessment preparation and execution of sanitization effectiveness study protocols with Microbiology Lab for active and new sanitizing agents on room and work surfaces.

• Assisting in investigations i.e. deviations during the execution of protocols and/or continuous monitoring activities and providing documentation to support the findings of the investigation.

• Lead development projects when modifications are required and implementation of new cleaning equipment/processes.

• Preparing SOPs and providing training to staff on the cleaning validation approach procedures.

• New cleaning equipment URS FAT SAT IQ OQ and PQ document generation and execution.

• Perform periodic cleaning validation verification studies.

• SME for presentation of cleaning validation to Regulatory (FDA) internal and external auditors.

• Equipment and Process Validation Responsibilities Scheduling planning and execution of equipment and process qualifications meeting approved schedules.

• Coordinating validation activities with other departments. Experience with Equipment and Instrument Standards used for validation executions.

Education and Experience:

• Minimum of a bachelors degree in a scientific discipline (e.g. Microbiology Biology Engineering or Chemistry); and at least five (5) years of cleaning validation in a pharmaceutical operation or relevant experience.

Technical Skills:

• Keeps abreast of current developments and trends in areas of expertise.

• Ability to independently write clear and concise technical reports process descriptions and standard operating procedures.

Physical Demands Mental Requirements and Work Environment:

• While performing the duties of this job the employee is regularly required to sit stand walk talk and hear.

• The employee is required to use hands to finger handle or feel.

• Specific vision abilities required by this job include close vision for written work and PC use.

Mental Requirements:

• Ability to hear accurately the spoken word with moderate office noise or plant noise.

• Ability to apply deductive reasoning and understand complicated issues.

• Ability to receive instructions and follow work rules and company policies.

• Ability to follow safety and security practices.

• Ability to meet deadlines and effectively deal with office stress.

• Ability to accurately communicate ideas facts and technical information.

• Maintain confidentiality of certain information.

Disclaimer:

The list under Essential Functions and Additional Responsibilities is not exhaustive but merely the most accurate list for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change. This position description in no way states or implies that the responsibilities and tasks are the only responsibilities and tasks to be performed by the employee occupying this position. She/He will be required to follow any other instructions and to perform any other jobrelated duties as required by his/her supervisor/manager. Requirements stated are minimum levels of knowledge skills and/or abilities to qualify for this position. To perform the duties and responsibilities of this position successfully employee will possess the abilities and aptitudes to perform each task proficiently. Employment decisions including promotions transfers and others are based on meeting all requirements and on organizational needs the employee being in good standing (including lack of disciplinary actions) meeting all applicable performance standards and other nondiscriminatory criteria. The methods of fulfilling requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT IMPLIED OR OTHERWISE. WE MAINTAIN AN AT WILL EMPLOYMENT.