Specialist Manufacturing

Weil Group • Juncos, PR

1d

About The Position

We are seeking a visionary Specialist Manufacturing professional to drive production excellence at the intersection of precision engineering and automation. In this role, you will optimize advanced manufacturing processes, implement cutting-edge Industry 4.0 technologies, and scale production lines to deliver next-generation products that shape our industry.

Requirements

• Doctorate OR Master's + 2 years of Manufacturing Operations experience OR Bachelors + 4 years of Manufacturing Operations experience OR Associates + 8 years of Manufacturing Operations experience OR High school/GED + 10 years of Manufacturing Operations experience.
• Detailed technical understanding of bioprocessing unit operations.
• Skilled in performance of GMP production operations.
• Regulatory knowledge and interactions.
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
• Organizational, technical writing and presentation skills.
• Basic project management skills.
• Basic knowledge of control charting.

Nice To Haves

• What attributes (i.e. - preferred qualifications) would make this candidate stand out?

Responsibilities

• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Assist in the generation of training materials and may assist in providing training on scientific or technical aspects of the process.
• Ensures that processes, and procedures are aligned with cGMP requirements and/or other applicable regulations.
• Responsible for ensuring that risks are identified, assessed, and corrected to ensure the safety, purity, quality, and efficiency of the product(s) manufactured.
• Responsible for ensuring that the Electronic Batch Record is aligned with the current process and may assist in providing training.
• Assist with generation and the implementation of process validation protocols and reports.
• Participate in regulatory inspections.
• Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• Assess, prioritize, support, and provide implementation and project management support for process or equipment modification projects.
• Own Change Control and ensure implementation within the established goal.
• Assist manufacturing change owner on CCRB packages impacting the process.
• Participate in noncommercial activity runs to support the collection and analysis of process data.
• Participate on the assessment or implementation of special projects or initiatives.
• Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions.
• Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
• May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
• Provide troubleshooting support.
• Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
• Provide support of timely execution of the process monitoring quarterly reports.
• Ensure that all Non-conformances are triaged within the established goal.
• Responsible for authoring investigation reports.
• Responsible for execution of corrective actions.
• Responsible for managing NC/CAPA closure within established goal.
• Monitor and communicate incidents trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• Assist with the execution of the process validation.
• Support collection and analysis of process validation data.
• Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
• Assist manufacturing change owner on CCRB packages impacting the process.
• Participate on the assessment or implementation of special projects or initiatives.
• Other functions may be assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed