CSV Engineer
3 weeks ago
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 SummaryWe are seeking a highly skilled CSV Engineer to support our Manufacturing Execution System (MES) for Electronic Batch Records. The successful candidate will be responsible for developing and implementing MES system life cycle strategy and business/technical processes for change management.
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, etc.
- Execute CSV protocols and generate validation documents.
- Write software configuration documentation, including validation plans, test cases, and validation summaries.
- Provide support in a variety of CSV tasks and participate in computer system validation project activities.
- Initiate and oversee system CSV associated change control requests and associated validation documentation.
- Author, review, and approve scheduled periodic reviews.
- Collaborate with project stakeholders and the information systems team to define needs and achievable solutions.
- 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.
- 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.
- Financial Perks and Discounts.
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.
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CSV Engineer
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Fort Worth, Texas, United States PSC Biotech Full timeJob Title: CSV EngineerPSC 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...
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Fort Worth, Texas, United States PSC Biotech Full timeJob Title: CSV EngineerPSC Biotech is seeking a skilled CSV Engineer to support the development and implementation of our Manufacturing Execution System (MES) for Electronic Batch Records. As a CSV Engineer, you will play a critical role in ensuring the accuracy and efficiency of our MES system.Key Responsibilities:Develop and implement MES system life cycle...
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Fort Worth, Texas, United States PSC Biotech Full timeAbout the RoleWe are seeking a highly skilled CSV Engineer to support our MES system for Electronic Batch Records. As a key member of our team, you will be responsible for developing and implementing the MES system life cycle strategy and business/technical processes for change management.Key ResponsibilitiesConfigure, program, troubleshoot, and test the MES...
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