Cleaning Validation Engineer

POSITIONDESCRIPTION

Position Title : CleaningValidation Engineer

Department : Validation

ReportsTo : Head of Engineering

Work Location : DecaturIllinois

PositionSummary :

The successful candidate is an SME in cleaning andsanitization effectiveness validation and has knowledge ofequipment and process validation.

The Engineer prepares productcontact surface cleaning and room and equipment sanitizationeffectiveness validation process and equipment validation protocolsprotocol final reports and procedural documentation.

Responsibilities includecoordinating validation activities with departments and personneland maintaining the cleaning validation processes andprocedures.

As thecleaning validation SME the candidate is knowledgeable in cleaningvalidation concepts practices procedures and leads and instructsothers supporting cleaning validation deliverables.

Essential Duties& Responsibilities :

Cleaning Validation Responsibilities Writingand reviewing cleaning and sanitization procedures and maintainingthe Cleaning Validation Master Plan.

Execution of cleaning validation protocolactivities and sample collection.

Responsible for adherence to FDA guidance and regulatoryrequirements and Rising Pharma Validation Master Plans.

Preparing reviewing and executingrelated validation studies such as extraction and recovery studiesfor product contact surfaces and equipment surfaces.

Preparing and executing cleaningdevelopment protocols including lab scale full scale spray coveragetesting and fullscale cleaning recipe and proceduredevelopment.

Preparingrisk assessment and reports summarizing data and determination ofcleaning matrix and critical cleaning parameters for validation.

Assess new products being introduced to the site for alignmentwithin the approved cleaning matrix.

Assessment preparation and execution ofsanitization effectiveness study protocols with Microbiology Labfor active and new sanitizing agents on room and worksurfaces.

Assisting ininvestigations i.e. deviations during the execution of protocolsand / or continuous monitoring activities and providing documentationto support the findings of the investigation.

Lead development projects when modificationsare required and implementation of new cleaningequipment / processes.

Preparing SOPs and providing training to staff on thecleaning validation approach procedures.

New cleaning equipment URS FAT SAT IQ OQ and PQdocument generation and execution.

Perform periodic cleaning validation verificationstudies.

SME forpresentation of cleaning validation to Regulatory (FDA) internaland external auditors.

Equipment and Process Validation ResponsibilitiesScheduling planning and execution of equipment and processqualifications meeting approved schedules.

Coordinating validation activities with otherdepartments. Experience with Equipment and Instrument Standardsused for validation executions.

Education andExperience :

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

Technical Skills :

Keeps abreast of currentdevelopments and trends in areas of expertise.

Ability to independently writeclear and concise technical reports process descriptions andstandard operating procedures.

Physical Demands Mental Requirements andWork Environment :

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

The employee is required to usehands to finger handle or feel.

Specific vision abilities required by this job includeclose vision for written work and PC use.

MentalRequirements :

Ability to hear accurately the spoken word with moderateoffice noise or plant noise.

Ability to apply deductive reasoning and understandcomplicated issues.

Ability to receive instructions and follow work rules andcompany policies.

Abilityto follow safety and security practices.

Ability to meet deadlines and effectively dealwith office stress.

Ability to accurately communicate ideas facts andtechnical information.

Maintain confidentiality of certain information.

Disclaimer :

The list under Essential Functions and AdditionalResponsibilities is not exhaustive but merely the most accuratelist for the current job.

Management reserves the right to revisethe job description and to require that other tasks be performedwhen the circumstances of the job change.

This position descriptionin no way states or implies that the responsibilities and tasks arethe only responsibilities and tasks to be performed by the employeeoccupying this position.

She / He will be required to follow anyother instructions and to perform any other jobrelated duties asrequired by his / her supervisor / manager.

Requirements stated areminimum levels of knowledge skills and / or abilities to qualify forthis position. To perform the duties and responsibilities of thisposition successfully employee will possess the abilities andaptitudes to perform each task proficiently.

Employment decisionsincluding promotions transfers and others are based on meeting allrequirements and on organizational needs the employee being in goodstanding (including lack of disciplinary actions) meeting allapplicable performance standards and other nondiscriminatorycriteria.

The methods of fulfilling requirements are subject topossible modification to reasonably accommodate qualifiedindividuals with disabilities.

THIS DOCUMENT DOES NOT CREATE ANEMPLOYMENT CONTRACT IMPLIED OR OTHERWISE. WE MAINTAIN AN AT WILLEMPLOYMENT.