Computer Systems Validation Engineer

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This range is provided by Corden Pharma - A Full-Service CDMO. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$/yr - $/yr

Corden Pharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.
Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms:
Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.
Our People Vision
We strive for excellence. We share our passion. Together, we make a difference in patients' lives.
Summary
This position is responsible for maintaining a comprehensive IT-BS Validation Program for the qualification of manufacturing, lab, and business-based computer systems to remain in compliance with GMP Regulatory and I-TS computer systems/data security expectations; specifically Annex 11 & 15. These services must align with FDA and EMEA Regulatory standards, be tailored to meet specific internal and/or client contract requirements and align with the IT-BS products/services of our parent company.
Essential Duties And Responsibilities
Include the following. Other duties may be assigned.

• Lead the Computer Systems Validation Program and activities as part of the overall IT-BS Department service for Corden Pharma
• Close liaison with the building contractors, engineers, and vendors of the facility to ensure full and appropriate information is provided; along with vendor qualification protocols, as needed for a comprehensive IT-BS Validation Program
• Implement and support IQ/OQ and technical qualifications as appropriate of Plant, Lab, and Business Computer Systems
• Authorship and review of documentation; and advising team members on best practices
• Lead training for compliance within CDMO Industry for IT-BS Group
• Responsible for the execution and oversight of ongoing (DQ, IQ, OQ, PQ) validation activities
• Review of vendor protocols and creation or approval of in-house protocols; and reports to deliver a complete package of qualification documentation
• Responsible for the continuous improvement of computer system validation by improving efficiency and productivity
• Responsible for timely authorship and routine review of SOPs and Quality documents in collaboration with IT-BS Management
• As some validation activities will be outsourced, the role will maintain these vendor relationships, including monitoring KPIs so that performance and value for money is maintained
• As a key service to the Quality Team, this role will contribute to the overall validation strategy for the site, as well as act as a technical point of contact for internal and external stakeholders
• Responsible for internal and external audit response with respect to SME delegation for data integrity, CSV, CSQ, CSA, and general IT-BS topics
• Key contributor for site project teams in the validation of IT-BS related computer systems; and equipment for all manufacturing, lab, and business areas working full-time on design, build and qualification activities, and improvements
• Work effectively and supportively with other project team members to deliver on client needs within the GMP manufacturing facility, in accordance with the program and scope of work
• Draft and review GMP documentation including validation documentation and training documentation
• Demonstrate self-directed learning and obtain/maintain technical certifications as appropriate to the needs of a comprehensive computer validation professional
• Understand the sites’ production schedule and work closely with Manufacturing and Engineering to build an IT-BS Qualification Schedule that delivers minimum interruption to manufacturing output
• Work in a safe manner, ensuring full compliance to SHE (Safety, Health, & Environment) policies
• Participate in and respond to IT-BS System inspection requests by regulatory authorities and client audit teams representing the IT-BS functional group
• Act as the primary point of contact for computer systems periodic reviews and practices, as required
• Participate in continuous improvement of the manufacturing facility to enable production to be conducted effectively, efficiently, and within regulatory compliance
• Establish and maintain strong relationships with cross-functional departments
• Actively maintain and update knowledge and expertise of current developments, standards, and operating practices within the pharmaceutical…