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Summary:
Develops and maintains the cleaning validation requirements ensuring compliance with the applicable business and regulatory standards. Support site cleaning and cleaning validation processes from product development through the product lifecycle. Revise and train on cleaning procedures, and educate those performing the cleaning on the expectations and intent of cleaning, inspection, and cleaning verification sampling. Documents the performance and compliance of the cleaning validation program.

Essential Duties and Responsibilities:

Duty (List no more than 5) % of Time (Total = 100%)

Develops validation deliverables, which comply with regulatory guidelines and business requirements. Develop procedures for cleaning processes utilized in operations including cleaning, inspection, and cleaning verification work instructions. Optimize and improve the consistency and effectiveness of cleaning processes. Support employee training to ensure compliance to procedure and process effectiveness. Conduct periodic reviews of the compliance of cleaning processes to the validated state and to ensure the effectiveness of the cleaning validation program. Assist and represent, as needed, in regulatory inspections.

These tasks are performed:
To ensure compliance with regulatory and corporate guidelines which keep systems in a validated state
To ensure the needs of the business are being met in an appropriate time frame
To prevent cross-contamination of drug products or cleaning agents, and maintain the validated state of product/equipment/cleaning methods
To educate those performing the cleaning on the expectations and intent of cleaning, inspection, and cleaning verification sampling

These tasks are accomplished by:
Authoring and/or reviewing technical documents/reports
Reviewing internal procedures and policies
Using Technical skills and attention to detail to ensure quality and timeliness of documents
Understanding the core concepts behind cleaning and cleaning verification
Develops and presents training material
Identifying and implementing continuous improvements to cleaning, inspection and sampling processes. (30%)

Support the change control process to ensure continuous documentation of the validated state. Support the Master Data and execute product, equipment, and system evaluations using a risk based approach including performing required calculations. Coordinate data collection, organization, and archival for cleaning validation program including testing for new and existing products, changes to cleaning processes or equipment, and new equipment. Coordinate sampling logistics (batch identification and tracking).

These tasks are performed:
To ensure compliance with regulatory and corporate guidelines which keep systems in a validated state
To ensure the needs of the business are being met in an appropriate time frame
To ensure CV samples are taken when required
To ensure real-time monitoring of CV results, and to ensure reports are written in a timely manner
To ensure validation status is accurately reported

These tasks are accomplished by:
Using Technical skills to evaluate characteristics which impact cleaning and cleaning verification
Performing surface area and limit calculations
Using Technical skills and attention to detail to ensure quality of data
Maintaining a program consistent with current company and industry requirements
Assess new products for cleanability and determine if cleaning validation is required for them (30-35%)

Participates in the development of appropriate testing strategies including swabbing location. Support the optimization of processes including manual and automated cleaning processes. Support the development of cleaning activities to ensure that the system's validation state is maintained. Design and author technical protocols and reports in alignment with the philosophy defined by the Cleaning Validation engineering team. Compile cleaning verification and validation data, investigations, and change control information for technical reports related to the cleaning program. Track equipment and product qualification status.

These tasks are performed:
To ensure policies, procedures, and practices keep systems/processes in good standing and in a validated state
To document and maintain the validated state of cleaning processes
To ensure validation status is accurately reported
Support life cycle implementation of new detergents, new CIP systems, and process improvements

These tasks are accomplished by:
Keeping abreast of industry trends and expectations from corporate requirements and regulatory agencies
Maintaining program consistent with current requirements
Conducting meetings with internal and external groups to outline expectations
Understanding core concepts behind cleaning and cleaning validation
Maintaining program consistent with current requirements
Evaluation of equipment for sample locations using multiple criteria including product properties which impact cleaning, equipment usage, site sampling ease
Ensure documents/systems are aligned to decisions
Authoring technical documents/reports using approved templates
Using Technical skills and attention to detail to ensure quality of data and thorough analysis.
Using knowledge of cleaning and cleaning validation requirements to ensure requirements of the protocol are met (20-25%)

Participates in the creation of policies, procedures, guidelines, and templates in the area of validation. Identify testing approach and cleaning swab sample locations on new equipment and/or for new products in alignment with the philosophy defined by the Cleaning Validation engineering team.

These tasks are performed:
To ensure compliance with regulatory and corporate guidelines
To create clear guidance and expectations for the company concerning validation
Reviewing internal procedures and policies
Using technical skills and attention to detail to ensure quality and timeliness of documents
Gaining consensus on modifications
Determining necessary routing and working with document coordinators to route for approval

These tasks are accomplished by:
Assembling and leading cross-functional teams
Gaining consensus on modifications
Determining necessary routing and working with document coordinators to route for approval
To document and maintain the validated state of cleaning processes
Support implementation of new equipment and products
Evaluation of equipment for sample locations using multiple criteria including product properties which impact cleaning, equipment usage, site sampling ease
Understanding core concepts behind cleaning and cleaning verification
Ensure documents/systems are aligned to decisions (10%)

Other duties as assigned.

Qualifications (Education, Experience, Competencies, etc.)

Bachelor's degree in engineering or related scientific discipline required with a minimum of four (4) years of Pharmaceutical industry experience in quality, production, engineering or a laboratory setting. Require 1-3 years specific cleaning validation experience in a pharmaceutical environment. Experience by a combination of equipment qualification, process validation, or cleaning validation is acceptable. In lieu of degree, minimum of six (6) years of experience in a manufacturing environment of which two years must include direct manufacturing and/or equipment cleaning experience within the pharmaceutical industry.

Quality experience in the pharmaceutical industry is preferred. Demonstrated ability in problem solving and critical thinking skills, support the corrective and preventative actions (CAPA) and implementation plans.

Demonstrated knowledge of project management skills and techniques, ability to prepare timelines and schedules to ensure projects are executed on time. Excellent organization skills with demonstrated ability to manage multiple projects and deadlines simultaneously. Self-directed individual.
Demonstrated skills in multitasking in an environment of high volume projects. Proven ability to shift thought processes quickly and accurately from one project to another.

Demonstrated ability for independent work that requires multi-tasking and a high level of attention to detail.

Demonstrated ability to facilitate and/or be an active participant on teams.

Experience with the authoring and execution of Quality documentation including validation documentation, technical protocols and/or technical reports.

Knowledge of FDA Current Good Manufacturing Practices (cGMP), ISPE's Risk-Based Manufacture of Pharmaceutical Products, and ICH Q9 Quality Risk Management.
Experience and Inspection interaction with FDA, EMA or other regulatory agencies preferred.

Demonstrated proficiency in interpersonal communications, both written (technical writing required) and verbal. Demonstrated successful communication/collaborative skills, influencing skills, and negotiation skills to manage conflicting and/or multiple demands, opinions, and expectations including ability to facilitate meetings as well as present to various levels within an organization.

Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (W