Medical Device and Pharmaceutical Manufacturing Systems Analyst
1 week ago
Diverse Lynx LLC is a dynamic company that values diversity across all levels. We promote an inclusive work environment where every individual can thrive.
Job Summary
We are seeking an experienced Systems Analyst to join our team. The successful candidate will have expertise in high-performance teams, data-driven solutions, and regulatory compliance.
Responsibilities
- Collaborate with business SMEs to understand paper Batch records and business process flows.
- Design and implement technology solutions for business systems analysis, ensuring GxP, ISO, and regulatory compliance.
- Develop and execute shopfloor transactions using OpCenter Execution Discrete in discrete manufacturing industries.
- Utilize Camstar (V8.x) Modeling Configuration, Designer, OpCenter Connect MOM, and Portal studio for Medical Device/Pharma industries.
- Leverage experience in C# and object-oriented programming concepts.
- Author Computer System Validation (CSV) documents, including Functional Risk Assessment, Validation Plan, System Test Plan, and Validation Report.
- Perform IQ (application and devices), OQ (including Siemens CAMSTAR/OpCenter MES System integration with SAP, Client, and other L3/L2 systems).
- Contribute to Key user and end-user training content creation based on standard Siemens CAMSTAR/OpCenter MES System product training material.
Requirements
- 5+ years of experience in system analysis, preferably in the Medical Device and Pharmaceutical manufacturing industries.
- Expertise in Camstar, OpCenter, and related software.
- Strong understanding of business processes, GxP, ISO, and regulatory compliance.
- Familiarity with C# and object-oriented programming concepts.
- Excellent communication and collaboration skills.
Benefits
We offer a competitive salary range of $80,000 - $110,000 per annum, depending on experience. Additional benefits include a comprehensive health insurance package, 401(k) matching program, and generous paid time off.
Salary Range:
$80,000 - $110,000 per annum
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