MES Systems Optimization Specialist
3 weeks ago
We are seeking a highly skilled MES Systems Optimization Specialist to play a key role in the design and implementation of a PAS-X system for our state-of-the-art drug product and finished goods facility.
Responsibilities:
- Collaborate with internal stakeholders to define MES requirements and develop User Requirement Specifications (URS) and Functional Requirement Specifications (FRS)
- Design and configure PAS-X workflows to automate and optimize manufacturing processes
- Integrate PAS-X with existing enterprise systems (e.g., ERP, LIMS)
- Develop and execute system validation plans
- Provide ongoing support and training to end-users
- Provide onsite support for projects and collaboration in Cary, NC
Qualifications:
- Bachelor's degree in Engineering or related field
- Minimum 5 years of experience in MES design, configuration, and implementation
- At least 2 years of experience working specifically with PAS-X systems
- Strong understanding of GAMP 5 and FDA CFR Part 11 requirements
- Excellent analytical and problem-solving skills
- Proven ability to manage multiple projects simultaneously
- Effective communication and interpersonal skills
Compensation:
$90 - $110/hr, depending on experience, degree, and qualifications. Medical, Dental, Vision insurance available. 401k Enrollment Available. 1099 can be considered.
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