Validation Engineer - Cleaning

Disability Solutions - Chelsea, MA

Full-time - Entry Level

Chelsea, MA

About the position

The Cleaning Validation Engineer at Catalent is responsible for coordinating all cleaning validation and verification activities related to Drug Substance and Drug Product manufacturing. This role involves close collaboration with various departments to ensure compliance with regulatory and customer requirements while providing excellent customer service. The engineer will define and apply cleaning strategies for all products and equipment at the site, support current operations, and participate in audits.

Responsibilities

• Be the site SME for the validation of cleaning processes.
• Ensure that all validations are performed according to regulatory, site, and customer requirements.
• Integrate production needs and ways of working into the cleaning strategy.
• Communicate across all departments on the cleaning strategy implementation.
• Author validation and procedure documentation including Cleaning Validation protocols, reports, and discrepancies.
• Investigate deviations and execute corrections or develop preventive actions.
• Define and execute improvement projects to enhance cleaning validation strategy and customer/site support.
• Participate in customer and regulatory audits.
• Engage in other process engineering activities as assigned.

Requirements

• Bachelor's degree required, preferably in an Engineering or Scientific discipline; Master's degree preferred.
• Minimum three (3) years of experience in the Pharma, Medical Device, or any GMP regulated environment required.
• Minimum of two (2) years' experience in Cleaning Validation required.
• QbD experience preferred.
• Excellent oral and written communication skills.
• Ability to effectively manage time and prioritize tasks independently.

Nice-to-haves

• Experience in a dynamic, fast-paced work environment.
• Familiarity with community engagement and green initiatives.

Benefits

• Defined career path and annual performance review.
• Diverse, inclusive culture.
• Positive working environment focusing on continual improvement.
• 152 hours of paid time off plus 8 paid holidays.
• Generous 401K match.
• Company match on donations to organizations.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement for further education.
• WellHub program to promote overall physical wellness.
• Exclusive discounts from approximately 900+ merchants.