Serve as the primary support for the MES Syncade system, ensuring its seamless integration with manufacturing processes.
Develop a deep understanding of manufacturing workflows to optimize and enhance processes with MES.
Review Functional Requirement Specifications (FRS) and test scripts for alignment with manufacturing.
Independently design experiments and evaluate data in support of improvements and investigations.
Support failure investigations and implementation of solutions (CAPAs) that solve manufacturing and product problems, follow up on CAPAs to determine effectiveness and suitability and prepare/review written reports in a timely fashion.
Draft technical reports in support of manufacturing process changes, optimizations, and regulatory filings.
Provide technical guidance and leadership to lesser experienced team members.
Ensure maintenance/ required control of records of qualification and validation, Change Controls, Risk Assessments and CAPAs for future compliance audits.
Requirements:
The ideal candidate must have knowledge of process manufacturing, field instrumentation, control system installation and implementation expertise in all of the following project phases: Requirements documentation, detailed design generation, implementation, system integration, testing and on-site startup. Plans and coordinates technical design and engineering implementation of project work.
4 - 6 years of role relevant experience
Strong understanding of biological process validation activities including drug substance manufacturing processes, drug product filling processes, process simulations (media fills), filtration, mixing, sterilization, lyophilization, and completion of validation risk assessments and evaluations.
Ability to mentor and guide lesser experienced team members.
Ability to communicate effectively with clients.
Proven ability to identify areas of business expansion and report to management team for follow-up.
Strong understanding of the three stages of Process Validation: Process Design, Quality Control, and Continuous Process Verification.
Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate.
Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client's organization.
Intermediate Microsoft Project capabilities.
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