Manufacturing Engineer
Designs, specifies and installs new equipment and provides engineering technical support and troubleshooting for all cell culture, purification and processing equipment. Provides project engineering as required for new processing equipment installations and modifications to existing equipment. Able to manage small engineering projects with little direction. Works with and provides some direction to contractors. Participates in multi-function teams to implement change and improve on existing processes.
• Provides responsible engineering support for a single area of a manufacturing facility containing processing & support equipment
• Troubleshoots equipment systems and supports associated automation system troubleshooting efforts.
• Identifies and leads equipment related projects, including technology transfers, capital projects, and modifications.
• Develops and supports equipment commissioning and qualification (validation) activities.
• Maintains personal training, goal development / completion, compliance workflow tracking, & progress tracking.
• Assesses equipment needs and generates equipment user requirement specifications for fabrication or purchase
• Helps implement new manufacturing processes and technology transfers as needed for new products or modifications to existing products.
• Investigates process or equipment failures and implements changes to avoid future occurrences.
• Manages and tracks completion timelines for compliance tasks (change controls, deviation investigations, corrective & preventive actions)
• Supports creation of new procedures for equipment and systems in Engineering and Manufacturing.
Experience Requirements:
• 2 – 3 years' experience in pharmaceutical or biotech manufacturing environment
Skills and Qualifications:
• Practical knowledge and application of GMP and EMEA regulations.
• Two to three years' experience in pharmaceutical or biotech manufacturing environment
• Competency in Delta V, MS Word, MS Excel, MS Power Point and MS Project.
• Excellent oral and written communication skills.
• Ability to work rotating shifts, extended shifts and weekends as needed.
• Assignments are moderately complex in nature where ability to recognize deviation from accepted practice is required. Judgment is required in resolving problems & making routine recommendations.
• Broad understanding of the detailed aspects of the job.
• Applies job skills and company policies and procedures to complete a variety of tasks.
Qualifications
Education Requirements:
• Bachelor's Degree with a minimum of 2 - 3 years related industry experience, or an MBA/MS