Job Description: Pay Range: $34.00/hr on W2 How will your role make a difference? As a Process Engineer, you will be an integral part of a cross-functional team tasked with aiding the site's operational team in problem-solving, process implementation, and investigative management, both independently and collaboratively. In this role, you will provide crucial support to the manufacturing operational team by addressing daily quality issues and leading various initiatives, agendas, and projects.
What will be your responsibilities? The ideal candidate will demonstrate exceptional interpersonal and communication skills, along with a track record of successful project management, experience in process improvement, and proficiency in technical writing. You will have numerous opportunities to positively impact daily challenges faced by the team and contribute to process enhancements, potentially involving capital investments. Your primary responsibilities include:
- Develop precise and concise work instructions tailored to technical and scientific manufacturing procedures.
- Innovate and formulate procedures that align with product specifications and uphold rigorous quality standards.
- Analyze historical production records and manufacturing documents to gather relevant data and insights into existing processes.
- Prepare investigation and root cause analysis reports in compliance with established quality standards.
- Foster close collaboration with manufacturing department personnel to determine optimal document formats and identify methods, protocols, and best practices to integrate into the instructions.
- Oversee the creation and maintenance of documents using an electronic document management system.
- Ensure adherence to SKU data standards and supply chain prerequisites that impact SKU configuration.
- Collaborate with team members to efficiently distribute workloads, monitor project progress, and conduct thorough reviews of colleagues' work to ensure accuracy.
- Develop procedures that align with product specifications and stringent quality requirements.
- Take ownership of designing validation documents and oversee their implementation to completion.
- Lead initiatives for the implementation of Corrective and Preventive Actions (CAPA) to rectify deviations and address customer complaints, contributing to continuous process improvement.
- Utilize internal software systems, including ERP, SKU Wizard, and Product Lifecycle Management, to oversee the creation and modification of raw materials, sub-assemblies, and finished goods SKUs, ensuring accurate alignment with current manufacturing processes.
Qualifications Education / Experience: - Bachelor's degree in Sciences or Engineering (mandatory)
- Over 2 years of experience in a manufacturing environment or similar role
- More than 1 year of experience in an ISO or cGMP regulated manufacturing environment
- Essential technical writing experience
- Proficiency with ERP systems and a basic understanding of cost accounting and standard manufacturing financials
- Familiarity with Practical Process Improvement (PPI) Systems and tools (or equivalent Continuous Improvement and Lean Systems)
- Previous experience working with multifunctional teams on projects of varying complexity
- Understanding of manufacturing processes and inter-departmental responsibilities
Knowledge / Skills: - Proficient in Microsoft Office Software, particularly Excel, Word, and PowerPoint
- Strong collaboration skills and the ability to influence others effectively
- Excellent verbal and written communication abilities
- Thrives in a fast-paced work environment
- Consistently meticulous and precise in executing responsibilities
- Maintains a positive attitude towards the job and colleagues
- Results-driven and data-focused
- Proficient in understanding manufacturing operational flows, including but not limited to Formulations, Protein Purification, Antibody Manufacturing, Filling, and Assembly/Packaging
- Possesses robust project management skills
- Proactively anticipates needs and identifies solutions to problems
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Last updated on Nov 8, 2023