Massachusetts Jobs

Cleaning Validation Engineer

Position Summary:

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

The Boston-area facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.

Catalent Pharma Solutions is hiring a Cleaning Validation Engineer who is responsible for coordinating all cleaning validation and verification activities related to Drug Substance and Drug Product manufacturing, while providing adequate customer service. This person works in close collaboration with other groups such as Operations, Quality, Product Development, Engineering, and Project Management. As an expert for the validation of cleaning processes, you are responsible for the definition and application of cleaning strategy applicable for all products/equipment of the site. This role will also support other activities, related to current operations and customers.

This is a full time, salaried role. The core hours are Monday – Friday 8:00AM – 5:00PM

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role

• Be the site SME for the validation of cleaning process;

• Ensure that all validations are performed according to the regulatory, site and customer requirements;

• Integrating the production needs and ways of working in the cleaning strategy;

• Good understanding of the production (cGMP) process;

• Being an interface between analytical development and production + follow-up of activities on the shopfloor;

• Communication across all departments on the cleaning strategy implementation;

• Ensure that all activities are performed in time and with due quality;

• Author validation and procedure documentation including, but not limited to Cleaning Validation protocols, reports, and discrepancies;

• Investigate deviations as per need and execute corrections and/or develop preventive actions;

• Define and execute improvement projects and initiatives to improve cleaning validation strategy and customer/site support;

• Participate in customer and regulatory audits;

• Can be involved in other process engineering activities;

• All other duties as assigned

The Candidate

• 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 or an equivalent combination of education, training and experience in any GMP environment required;

• Minimum of two (2) years’ experience in Cleaning Validation required or equivalent combination of education, training and experience required;

• QbD experience preferred;

• Excellent oral and written communication skills.

• Ability to effectively manage time and prioritize tasks independently to meet tight timelines and shifting priorities.

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• Positive working environment focusing on continually improving processes to remain innovative

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• 152 Hours + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• Community engagement and green initiatives

• Generous 401K match

• Company match on donations to organizations

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement – Let us help you finish your degree or start a new degree!

• WellHub program to promote overall physical wellness

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .