Cleaning Validation Engineer

THE COMPANY:

Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.

Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.

PRIMARY PURPOSE:

The Cleaning Validation Engineer is responsible in ensuring that cleaning validation activities within commercial and development facilities are compliant with both internal and regulatory standards. This position is responsible for minimizing product cross-contamination risks through the development, validation, and continuous improvement of cleaning processes and procedures. Acting as the Subject Matter Expert (SME) for cleaning verification and validation, the Cleaning Validation Engineer works across the site to manage all aspects of cleaning procedures for direct, indirect, and non-product contact surfaces in the manufacturing environment.

MAJOR DUTIES AND RESPONSIBILITIES:

• Lead development and maintenance of cleaning validation strategy compliant with US FDA requirements
• Create cleaning cycle development programs for a variety of equipment including: process vessels, clean-in place systems, packaging equipment, parts washers, and production facilities.
• Evaluate manufacturing process documents and equipment cleaning procedures for validation purposes
• Lead investigation and troubleshooting problems which occur during cleaning
• Responsible for planning and execution of onsite cleaning validation programs
• Prepare and review completed and executed validation packages by compiling and analyzing validation data for submittal for review and approval
• Lead resolution of cleaning deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval
• Collaborate with other departments to define protocol contents and actions
• Develop and author change controls for cleaning process or equipment changes
• Write and execute IQ/OQ/PQ and cycle development protocols including final reports.
• Maintain an up-to-date knowledge of validation requirements, practices, and procedures
• Write validation plans and risk assessments related to specific projects and facilities
• Facilitate the development of user requirement specifications and operational SOPs for equipment.
• Lead cleaning studies, spray coverage testing, cleaning verification swabbing, and risk sampling.
• Responsible for identifying appropriate facility cleaning/sanitizing agents; participates in cleaning/sanitizing effectiveness studies
• Develop, review, and revise standard operating procedures and guidelines for product and equipment cleaning
• Other duties as assigned

QUALIFICATION:

Required

Bachelor's Degree or equivalent in a scientific/pharmaceutical area

5+ years of cleaning validation or engineering work in GMP and FDA regulated environment.

Ability to independently generate protocols and reports for evaluation experiments.

Advanced knowledge of various analytical equipment and techniques utilized in an analytical laboratory.

Understanding of regulatory requirements related to cleaning validation and cleaning equipment/CIP design.

Experience in risk management and client service/project management

Demonstrated ability to work both independently and in a team environment.

Familiarity with production equipment and processing technologies.

Proficient in Microsoft Office programs (Word, Excel, Outlook, CAD) and CRM software

Travel up to 10%

Preferred Additional

Knowledge of EU and other global requirements & standards.

CRITICAL SKILLS AND ABILITIES:

• Demonstrated Analytical and Problem Solving Skills.
• Ability to elicit cooperation from a wide variety of sources, including upper management, customers, suppliers, board, and other departments.
• Excellent written and oral communication skills.
• Ability to lift up to 25 pounds.
• Ability to work in a dynamic environment with shift priorities.