Catalent Hiring for Senior Engineer, Computer System Validation job in Harmans Full Time

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 Senior Engineer – CSV will work in an FDA/EU regulated facility. This position is responsible for supporting the Process Validation and Cleaning Verification/Validation programs at the BWI site located in Harmans, MD. We are seeking for a candidate with experience in process validation and/or cleaning verification/validation with a hands-on approach to working with others to accomplish goals and objectives.

This position is 100% on site 1st Shift from Monday-Friday 8AM-5PM.

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:
o Author and review validation protocols including IQ, OQ, and PQ protocols related to Computer Systems for Manufacturing equipment such as bioreactors, TFFs, tube welders, AKTAs, glove integrity testers, filter integrity testers, controlled temperature units etc.
o Author and Review of Validation Deliverables – Validation Master Plan (VMP), System Impact Assessment, Detailed Risk Assessment, User Requirement Specification Document, Functional Specification/Design Specification Document, Configuration Specification document, 21 CFR Part 11 Assessment, Application Qualification Protocol (IQ/OQ/PQ), Validation Summary Reports; Review and Provide guidance on Deviations/Defects during the IOQ/PQ executions.
o Leads all aspects of validation efforts relating to computer systems; Ensure site systems are compliant with the corporate Data Integrity program.
o Authors and Reviews Data Integrity Assessments and Remediation plans; Participates in activities related to validation including design, maintenance, and change control.
o Support the Validation Lifecycle to ensure compliance to 21 CFR Part 11, Eudralex Annex 11 and applicable FDA/EMA Guidance.
o Tracks and communicates project status, as well as project risks and recommendations to stakeholders; Collaborate with manufacturing, engineering, facilities, and quality assurance to Responsible for maintaining computer systems and software in a valid state.
o Provide input into Requirements Specifications for new equipment at the facility; Participate in investigations and preventive/corrective actions for Validation including authoring and/or reviewing/approving Change Controls, CAPAs and Deviations
o Collaborates with other team members to ensure goals and objectives are achieved; Author, Review and approve Standard Operating Procedures (SOPs)
o Other duties as assigned

The Candidate:

• B.S. in Engineering
• 5 or more years of validation experience in a GMP environment; Knowledge of the Validation Lifecycle
• Experience in the following area highly desirable: Mixing and Holding studies; Tech Transfer and NPI
• Working knowledge of Kaye/Amphenol datalogging equipment (Validator, AVS, ValProbe) is desirable
• Experience with Trackwise, Gene therapy and media fills/smoke studies is preferable; Knowledge of statistics is preferable
• Able to work with minimum supervision

Why you should join Catalent:
• Defined career path and annual performance review and feedback process
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Dynamic, fast-paced work environment
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• 19 days of PTO + 8 paid holidays
• Employee Stock Purchase Program
• Tuition Reimbursement
• GymPass 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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers 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 [email protected] . 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 [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE .