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PAS-X System Design and Configuration Professional
2 months ago
Piper Companies is seeking a highly skilled MES Consulting Engineer 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.
Key Responsibilities- Collaborate with Internal Stakeholders: Work closely with cross-functional teams to define MES requirements and develop User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
- Design and Configure PAS-X Workflows: Design and configure PAS-X workflows to automate and optimize manufacturing processes, ensuring seamless integration with existing enterprise systems.
- Integrate PAS-X with Enterprise Systems: Integrate PAS-X with existing enterprise systems, such as ERP and LIMS, to ensure data consistency and accuracy.
- Develop and Execute System Validation Plans: Develop and execute system validation plans to ensure compliance with regulatory requirements.
- Provide Ongoing Support and Training: Provide ongoing support and training to end-users, ensuring they have the necessary skills to effectively utilize the PAS-X system.
- Onsite Support and Collaboration: Provide onsite support for projects and collaborate with internal stakeholders in Cary, NC.
- Bachelor's Degree in Engineering or Related Field: A bachelor's degree in engineering or a related field is required.
- Minimum 5 Years of MES Experience: A minimum of 5 years of experience in MES design, configuration, and implementation is required.
- At Least 2 Years of PAS-X Experience: At least 2 years of experience working specifically with PAS-X systems is required.
- Strong Understanding of Regulatory Requirements: A strong understanding of GAMP 5 and FDA CFR Part 11 requirements is essential.
- Excellent Analytical and Problem-Solving Skills: Excellent analytical and problem-solving skills are required to manage multiple projects simultaneously.
- Effective Communication and Interpersonal Skills: Effective communication and interpersonal skills are necessary to collaborate with internal stakeholders.
Piper Companies offers a competitive compensation package, including a hourly rate of $90 - $110, depending on experience, degree, and qualifications. Medical, dental, and vision insurance are available, as well as 401k enrollment.
