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

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.
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.

Nice To Haves

Experience of bio-processing unit operations
Knowledge in Root Cause Analysis methodologies (Fishbone, Six Boxes, Fishbone, 5 Why’s, Kepner Tregoe)
Familiar with Lean Manufacturing Practices
Proficiency in GDP (Good Documentation Practices) on a regulated environment
Knowledge in systems/Tools: Trackwise, VEEVA, MES, Smart Sheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms
Strong Technical Writing/presentation abilities, and excellent written/verbal communication skills in English and Spanish
Teamwork Oriented
Able to work under minimal supervision and/or high workload and pressure
Able to work extended hours
Excellent interpersonal skills

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.
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.
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.