| #Urgent Role For Process Validation Specialist Swiftwater, PA Onsite at Remote, Remote, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2307743&uid= From: Akash Kumar, Sonitalent Corp [email protected] Reply to: [email protected] Hi, Hope you are doing well, We are looking for Process Validation Specialist Please let me know if you are looking for this role and send me your updated resume also. Job Title: Process Validation Specialist Location: Swiftwater, PA (Onsite) Duration of project: 6 months+ Required visa: Any visa (Except H1B and CPT) Mode of Interview: Video Please provide two prior work references with work email and phone number MANAGER NOTES: Process Validation Proficient in MS Office Strong communication, proficient in English written and verbal Ability to write process validation documents and execute Process performance qualification skills required Manager does not want computer validation related roles, must have manufacturing on the floor experience, collect process samples Must gown up for role and best GMP practices Proficiency in Pi Previous micro fluidizer experience Accountabilities: Key contributor for strategy development and execution of development and process validation related to adjuvant manufacture. Provides input to industrialization strategies and rationale for critical process parameters. Subject Matter Expert (SME) for development and validation, and investigations. The individual in this position will work with a cross-functional team from various functions in M&S-V to deliver following: 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. 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. Responsibilities: 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). Fosters relationships with partners and customers in order to achieve technical objectives. BS or MS in basic sciences, math, engineering or pharmacy with 2+ years experience in biological processes or analytics in a cGMP environment. Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control. Excellent written and oral communication skills. Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members. Experience in equipment start-up, qualification and validation is preferred. Proficiency with PI Prior experience preparing and executing process performance qualification documents (PPQ) preferred. Thanks & Regards -- Akash Kumar Technical Recruiter, Sonitalent Corp Direct:8596593266 || https://www.linkedin.com/in/akash-kumar-151a8025a/ [email protected] Website: https://www.sonitalentcorp.com/ 5404 Merribrook Lane, Prospect, KY, USA . | | Keywords: microsoft Kentucky Pennsylvania #Urgent Role For Process Validation Specialist Swiftwater, PA Onsite [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2307743&uid= |
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| 07:20 PM 02-Apr-25 |