| JUNIOR Validation Engineer - MANUFACTURING at Junior, West Virginia, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1091823&uid= From: Naveen Varma, USG [email protected] Reply to: [email protected] Role: JUNIOR Validation Engineer - MANUFACTURING Location: Swiftwater, PA Duration: Long Term MUST HAVE'S : - MANUFACTURING EXPERIENCE - VERY GOOD Communication Skills - Willing to go on shop floor and execute the studies following GMP and good documentation practice. - This role will need to work with a transversal team, so interpersonal skills are important. Accountabilities: Write protocols, reports, procedures, and memos as needed to support adjuvant manufacturing activities as they relate to engineering, investigational, definition, development and process validation runs Support execution of development and validation related studies. Document and interpret study results with recommendations Provide technical leadership as an subject matter expert in multiple areas of responsibility Develop and execution of training programs for appropriate audiences Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines. Provide leadership, including project team leadership, within area of expertise Assist with assessing existing processes and workflows. Translate processes to commercial operations. Ownership of equipment unit operations and technology capabilities. Communicates findings and proposals to upper management. Improve Manufacturing Technology strategic programs by supporting non-conformance issues related to change controls, deviations, corrective and preventative actions (CAPAs). Participate in Gemba/ shop floor walk through to learn about production processes and / or interview stakeholders to collect data for continuous improvement of strategic programs and development of validation strategies/documents. Develop and update standard operating procedures and related technical documents to align to program strategies under a cGMP environment. Work closely with other members of the department to share knowledge and competencies encouraging individual growth and technical contributor. The Job Responsibilities Include: Write protocols, reports, procedures and memos as needed to support Adjuvant manufacturing activities related to engineering, investigational, definition, development and process validation runs Support execution and documentation of engineering, development and/or validation studies and lead or supervise groups and/task force in the planning of engineering, investigational, definition, development and process validation runs. Input to design space / DOE studies through establishment of scale-up / scale-down parameters utilizing engineering fundamentals (mixing, mass / heat transfer, modeling, dimensionless parameters, etc.) and process control strategies. Provide technical assistance to manufacturing and quality operations for process troubleshooting, improvement, technical transfer and health authority inspections to achieving site metrics (+QDCI). Behaves according to company values and competencies. Forward thinking with an attitude of collaboration, optimization, efficiency, continuous improvement. Effectively communicates successes, constraints, conflicts, solutions and actions for resolution. Proactively resolves conflicts, removes roadblocks to execution within sphere of influence; escalates to functional management when appropriate. Fosters relationships with partners and customers in order to achieve technical objectives. Thanks Naveen Varma [email protected] United Software Group Inc.. Keywords: golang Pennsylvania http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1091823&uid= |
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| 01:18 AM 07-Feb-24 |