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CSV and Qualification 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 Computer System Validation (CSV)/ Qualification Engineer is responsible for managing, developing, and implementing the Computer System Validation program and equipment qualification for the site to ensure compliance with local and global regulatory agency requirements, internal company standards, and current industry practices. Validation activities include equipment, instrument, cleaning, computer and process validation.

This is a full time, salaried role, The core hours are Monday – Friday 8:00AM – 4:30PM

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

• Performs and leads computer system validation projects related to reviewing, authoring, and executing specifications and validation documentation for process equipment/systems, laboratory automated instruments/equipment, and systems according to the GAMP5 Validation Life Cycle.

• Generate and/or support validation deliverables including validation project plans, system impact assessments, user requirements, test strategies, risk assessments, data integrity assessments, test protocols, and summary reports to address the Validation lifecycle in line with corporate guidelines procedures, CGMP, and ISPE GAMP guidelines and regulations.

• Identify specific tests and requirements to be met in the IQ/OQ/PQ that address system requirements.

• Ensure all work is in line with the site Master Validation Plan, regulations, procedures, and practices.

• Ensure that the site Validation Master Plan remains current and aligned with corporate policies.

• Perform Data Integrity Assessment (DIA) and System Impact Assessment (SIA) for Computerized Systems.

• Lead and conduct validation activities in compliance with US and EU regulations (regulations for all countries where have business) procedures and EHS requirements.

• Review and execute computer system validation protocols to ensure compliance and adherence with corporate guidelines procedures, CGMP, and ISPE GAMP guidelines and regulations.

• Write and review risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the site Validation Master Plan.

• Prepare validation summary reports for executed protocols.

• Communicate computer system validation approaches and requirements during audits.

• Generate and maintain computer system validation procedures in line with corporate guidelines procedures, CGMP, Corporate policies/standards, and ISPE GAMP guideline.

• All other duties as assigned

The Candidate

• Bachelor’s degree in Computer Science, or other Science, Technology, Engineering, Mathematics related field;

• Requires minimum of 5 years in a CGMP-related industry with at least three (3) to four (4) years of Computer System Validation experience working with cGMP pharmaceutical /nutraceutical regulated industries and 21 CFR Part 11 compliance (world CSV regulations);

• Familiarity with computer infrastructure, servers, workstations, Operating Systems, and database management systems;

• Familiarity with computerized pharmaceutical GMP systems such as LIMS, CDS, BMS, JDE, SAP, Analytical Instrumentation, Manufacturing and Packaging systems, Quality Management Systems, and their associated vendors;

• Must be trained in GMP Quality systems such as Change Control, CAPA and Deviation;

• Experience with Electronic Document Management and Learning Management Systems preferred (EDMS);

• Knowledge with Calibration Activities and Preventative Maintenance;

• 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) .