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CSV Engineer

2 months ago

Fort Worth, Texas, United States PSC Biotech Full time
About PSC Biotech

PSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products.

Job Summary

We are seeking a highly skilled CSV Engineer to support our MES system for Electronic Batch Records. The successful candidate will be responsible for participating in the development of MES system life cycle strategy and business/technical processes for change management, as well as configuring, programming, troubleshooting, and testing the system.

Key Responsibilities
  • Develop and implement MES system life cycle strategy and business/technical processes for change management.
  • Configure, program, troubleshoot, and test the MES system.
  • Complete project deliverables, including URS, FRS, OQ, PQ, VMP, TM, ECOs, etc.
  • Perform execution of CSV protocols.
  • Generate and execute validation documents, including System Testing, IQ, OQ, PQ, UAT.
  • Write Software Configuration Documentation, including validation plan, test cases, and validation summary.
  • Provide support in a variety of CSV tasks.
  • Participate in computer systems 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 deliverable 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
  • Medical, Dental, and Vision insurance.
  • Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability, and more.
  • 401(k) and 401(k) matching.
  • PTO, Sick Time, and Paid Holidays.
  • Education Assistance.
  • Pet Insurance.
  • Fitness Benefits (Membership discounts and other perks/services at qualifying gyms).
  • Financial Perks and Discounts.
Equal Opportunity Employment Statement

PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state, and local laws concerning employment discrimination.