- Education: Bachelors Degree in Science or Engineering Discipline
- Functional Area: Manufacturing
- Industry: Biotechnology & Pharmaceuticals
Job Title: Engineering - Project Coordinator
Location: Pearl River - NY
Duration: 06 Months Contract
The position performs manufacturing of commercial and clinical conjugate related products. Primary duties include performing all required complex manufacturing activities including production, investigation, equipment validation, writing SOPs, in compliance with company policy and regulations. Assist developing detailed plans and prioritize the routine tasks within the plan to achieve goals of incumbent’s projects. Actively develop technical and operational leadership on all aspects of the manufacturing operations and contribute to the success of the department.
• Muti-task all activities associated with manufacturing of commercial and clinical antibody drug conjugates including but not limited to operation, cleaning, investigation, change control, conducting training, etc. Heavy “hands-on” operations and irregular work schedules occasionally required. Function as a member of self-directed high performance team.
• Perform manufacturing of commercial and clinical batches in compliance with cGMP, Safety, and Environmental regulations. Meet the production demand. Ensure all Investigations and commitments are performed in a timely manner. Ensure all production equipment and systems are in compliance with cGMP.
• Create or modify Standard Operating procedures (SOPs) for commitment implementation or as related to new projects, facility and equipment changes. Evaluate and approve Preventive Maintenance Orders (PMOs). Initiate change controls related to new projects, facility and equipment changes, BR and PMO revision, etc.
• Assist in problem solving efforts for manufacturing processes. Troubleshoot process issues, diagnose technical problems and identify short- and long-term solutions. Work closely with cross-functional groups to resolve system problems to minimize contamination and cost.
• Conduct manufacturing deviation investigations and write investigation reports (MIRs). Identify root causes and corrective/preventive actions (CAPAs). Implement CAPAs commitments.
• Compliance - Perform other technical tasks as required to ensure GMP and safety compliance. Promote cGMP compliance within the work place by following site cGMP procedures. Incorporate cGMP and regulatory compliance into all assigned projects scope and design.
• Provide project team support as required by team leads.
Education experience: Bachelors Degree in Science or Engineering Discipline
Key Technical Skills for the Associate are as follows:
• Strong Technical Writing and Background
• Excellent Oral/Written Communication Skills
• Attention to Detail
• Problem Solving
• Ability to Manage Multiple Priorities
• GMP Manufacturing /Aseptic Processing Experience
Select Source International is a Global Solutions provider of IT staffing and Project services. Our service offering has 5 main practices; ERP, Application Development, Middleware, Database Management and Project Services. SSI offers industry leading Data Migration, Compliance, and Risk Management through its subsidiary Data Wave. Data Wave offers Cyber Security and risk management through a GRC product suite called Risk Utilities. In addition to our technology offerings, SSI also provides administrative and business consulting services. Industry Experience: Retail Healthcare Manufacturing Energy and Utilities Government Financial Engineering.
- Name: Sahil Sharma
- Email: firstname.lastname@example.org
- Phone: 9525463500
- Extension: 5041
- Name: Select Source International
- Website: www.selectsourceintl.com