Job Description
Our Client, a Biotech company, is looking for a MES Change Specialist for their Hillsboro, OR location.
Responsibilities:
Requirements:
Why Should You Apply?
Responsibilities:
- Troubleshoot and identify resolutions for mechanical or automation related failures in production
- Identify opportunities to improve leveraging data analytics of system performance to deliver reduced costs and increased efficiency.
- Lead user requirement gathering for operational needs and perform initial requirement assessments for MES modifications
- Own CSV functions including defining requirements, writing and execution of test scripts
- Translate operational requirements into recipe and workflow requirements that will define CSV test protocols
- Development, authoring, and executing of protocols for configuration verification (CV) and functional verification (FV) testing of MES recipes and workflows according to approved procedures and CSV principles
- Investigate and assess exceptions and deviations from CV and FV protocol testing
- Own plan, execute, and improve review of MES changes for a set of assigned manufacturing processes driven by the change management process, including testing and implementation
- Monitor project schedule and escalate concerns to leadership with appropriate time to mitigate
- Assist with drafting test plans for MES changes, including comprehensive test plans and/or reports for new recipes
- Own MES-related deviations, including high-complexity or multi-site deviations relating to MES defects. Ensure corrective actions resolve issues effectively
- Support MES-components of other site initiatives, including capitalized projects, tech transfers, Drug Substance/Drug Product (DS/DP) changes, shutdown projects, and new launches
- Serve as an audit support for MES, providing demonstrations, presentations, and answering questions as required. If topical, support closure of any MES-related regulatory findings.
Requirements:
- Hold a Bachelor’s degree in a relevant field plus 3-5 years of MES, electronic batch record, or computerized systems experience for regulated manufacturing OR Master’s degree in a relevant field
- Have prior experience with construction, testing, and validation of computerized systems
- Have extensive prior experience working in electronic change management systems (trackwise, Veeva, etc.) to own changes and coordinate action items spanning multiple departments
- Prior experience in IT, OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP), preferably in a regulated industry.
- Have a strong understanding of test requirements for electronic data systems for regulatory compliance
- Have knowledge of the automation systems that include SAP, Manufacturing Execution Systems (MES), Programmable Logic Controllers (PLC) and Human Machine Interfaces (HMI)
- Have prior experience with sterile pharmaceutical manufacturing (solution prep, equipment prep, liquid/lyo vial filling, PFS, formulation, inspection, packaging, etc)
- Ownership of changes in a change management system (ex. Veeva) from initiation to closure
- Have experience with troubleshooting Rockwell systems, including remote or on-site support, is strongly preferred
- It is preferred you have prior experience on an EBR or MES deployment projects.
- Must have experience working in a manufacturing environment
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
Numbers & Facts
| Location | Hillsboro, OR |
| Industry | Management Consulting Services |
| Salary | $66.50–$71.50 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | https://www.iconma.com/ |
Benefits
401K, Employee Referral Program, Life Insurance
About Company
ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.
- Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
- Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
- Founded in 2000
- 2000+ Employees
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.
Skills
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