Specialist Manufacturing

Weil Group•Juncos, PR

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.
Participate and help lead cross-functional teams.
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

Visionary Specialist Manufacturing professional to drive production excellence at the intersection of precision engineering and automation.
Optimize advanced manufacturing processes.
Implement cutting-edge Industry 4.0 technologies.
Scale production lines to deliver next-generation products that shape our industry.

Responsibilities

Own change controls for manufacturing process changes
Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections.
Support Risk Assessments exercises and Microbial assessment evaluations.
Led commercial campaign readiness and effectively communicate and collaborate with cross function areas.
Assist in the generation of training materials and assist in providing training on scientific or technical aspects of the process.
Provide commercial support when needed and assist on the floor troubleshooting.
Design, coordinate, and support execution of functional tests, water tests, and other runs to challenge process and operations during major changes, or campaign readiness. Generate technical protocols as needed.
Assist and provide guidance during MBR (Master Batch Record) creation/revisions.
Perform assessment to support process, automation, or equipment modification or implementation of special projects
Initiate, revise, and approve standard manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
Assess process performance and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
Complete assessments for CAPA applicability requests from other plants/sites
Complete assessment for new or changes in BOM's (Bill of Materials)
Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area.
With minimal supervision, 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.
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.
Provide troubleshooting support.
Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
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 generation of process validation protocols and reports.
Assist with the execution of the process validation.
Support collection and analysis of process validation data.
May participate in regulatory inspections, New Product Introductions, and Process or Equipment Modifications:
Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
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.