Computer Systems Validation Engineer

Corden Pharma Colorado

48d

About The Position

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 IT-BS 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.

Requirements

8 years of experience working in a GMP licensed facility that includes aseptic and/or sterile manufacturing
Three years of experience in validation of new and legacy GMP manufacturing and laboratory equipment
Proven experience of managing compliance to GMP regulations and guidance, including specifically 21 CFR Part 11 and Annex 11 & 15
Current working knowledge of GMP, with a deep understanding of validation within lab, manufacturing environments, and related equipment
Ability to work consistently and compliantly, following standard operating procedures and quality policies
Able to generate GMP documentation to a high standard and relating to validation, including policies, SOPs, protocols, and reports
Good communication skills; able to work with various team members across all functions
Good understanding of Quality Management Computer Systems; and having a controlled approach to identifying and reporting deviations, and completing CAPAs
Must have a Bachelor’s Degree in a Computer or Life Science related field, such as Programming, Computer Science, Engineering, Lab Computer Systems, Network Security, or Infrastructure.
Ability to read and understand common information technology technical literature.
Ability to effectively communicate verbally and in writing with peers, customers, and management.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to compute rate, ratio, percent, and to draw and interpret bar graphs.
Ability to apply problem solving and best judgement to assigned tasks.
Knowledge and ability applying problem solving, as demonstrated with schoolwork performance and work experience
Proficiency with the Microsoft Office Suite, Visual Basic, and SQL Scripting
Senior knowledge of computer Infrastructure Computer Systems (software and hardware)
Senior knowledge of instrumental analysis applications and analytical chemistry
Basic Active Directory administration experience
Familiarity with virtualization software, i.e., VMWare
Knowledge and experience with Windows XP/Windows 7/Windows 10
Familiarity with a networked client-server and/or Virtualized Computer System environment (e.g., TCP/IP, DNS, DHCP, etc.)
Analytical and troubleshooting skills
Ability to handle multiple tasks simultaneously
Excellent customer service and communication skills
Must be a team player and have the ability to multi-task
Project management skills
Willingness to learn new technologies

Nice To Haves

Experience in participating in the introduction of new processes and equipment into a GMP manufacturing facility
Previous knowledge and experience with Project Management including OPEX, Visual Management, and Six Sigma

Responsibilities

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 industries
Interact with Leadership, Project Management, clients and team members to achieve project goals
Represent stakeholders, translate business needs and technical issues, and lead requirement reviews
Scope the requirements/capabilities of IT-BS Lab Computer Systems, elicit project requirements for lab system implementations - especially the business requirements
Write the project requirements in a clear, concise manner
Act as a communication broker – work with the project designers and architects to make sure their designs conform to the project and IT-BS validation requirements
Provide technical assistance and support for incoming queries and issues related to lab-related computer systems, networks, telecommunications, software, and hardware
Support the configuration, administration, and training on the IT-BS validation components of various lab computer systems, manufacturing instruments, and IT-BS business services
Respond to inquiries from staff, administrators, service providers, site personnel and outside vendors etc. to provide technical assistance and support, regarding IT-BS validation requirements and regulatory needs
Ask questions to determine nature of problem and walk customers and IT-BS staff through the IT-BS validation problem-solving process
Subject matter expert for the department and our customers; with integrated IT-BS validation solutions and procedures that will ensure proprietary/confidential data and computer systems are protected, and address data-integrity/regulatory standards and expectations
Responsible for oversight of periodic review of IT-BS systems (and participation where needed)
Responsible for oversight of preventative maintenance of IT-BS systems (and participation where needed)
Responsible for process ownership for site CSV activities (and corporate CSV where needed)
System ownership as appropriate
Responsible for participation in corporate IT-BS initiatives where needed

Benefits

401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
Accident Plan
Critical Illness Insurance
Dental Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft Protection
Life Insurance
Paid Parental Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance