CSV Engineer

7 days ago

Fort Worth, Texas, United States PSC Biotech Full time
Job Title: CSV Engineer

PSC Biotech is seeking a skilled CSV Engineer to support our MES system for Electronic Batch Records. As a CSV Engineer, you will play a critical role in ensuring the accuracy and efficiency of our system configuration, programming, and testing.

Key Responsibilities:
  • Develop and implement MES system life cycle strategy and business/technical processes for change management.
  • Configure, program, troubleshoot, and test MES systems.
  • Complete project deliverables, including URS, FRS, OQ, PQ, VMP, TM, ECOs, and CSV protocols.
  • Generate and execute validation documents, including system testing, IQ, OQ, PQ, and UAT.
  • Write software configuration documentation, including validation plans, test cases, and validation summaries.
  • Provide support in a variety of CSV tasks, including planning, development, and implementation of computer systems validation documentation.
  • Initiate and oversee system CSV associated change control requests and associated validation documentation.
  • Author, review, and approve scheduled periodic reviews.
  • Participate in computer validation project activities and create computer system planning documents and testing protocols.
  • Review test results and identify areas of improvement to implement changes.
  • Review and modify Standard Operating Procedures (SOPs).
  • Review and analyze validation data, compiling reports when required.
  • Collaborate with project stakeholders and the information systems team to define needs and achievable solutions and/or justifications to system requirements.
Requirements:
  • 3-5 years of Computer Systems Engineering experience.
  • Technical background in IT/Engineering.
  • Experience working in the Pharmaceutical industry, preferably within eye care.
  • Experience in cGMP manufacturing environment.
  • Must have experience working with Siemens MES.
  • Ability to read and interpret dimensional specifications and drawings.
  • Experienced with strong knowledge in CSV deliverables, such as URS, FRS, OQ, PQ, VMP, TM, ECOs, etc.
  • Strong learning initiative.
  • Strong interpersonal skills and excellent communication skills.
  • Team player with the ability to work with internal and external suppliers.
Benefits:
  • PSC Biotech offers a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and education assistance.
  • We also offer a range of perks, including pet insurance, fitness benefits, and financial discounts.
  • PSC Biotech is committed to equal employment opportunity and welcomes applications from diverse candidates.

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