Specialist Manufacturing

Weil Group, Inc; Juncos (PR); On-site; USD 95,000 - 130,000; Full time

Job summary

Weil Group, Inc. is seeking a Specialist Manufacturing to optimize production with Industry 4.0 tech and scale precision processes.

The role focuses on external supply quality change control, cross-functional leadership, and rigorous documentation practices to ensure timely CCR closure. With expertise in TrackWise and SAP, the candidate will drive process improvements, validation, and regulatory readiness while collaborating across manufacturing, quality, and supply teams in a dynamic

Qualifications

• Advanced bioprocessing knowledge required.
• Experience with GMP production operations.
• Regulatory knowledge and interactions.
• Strong cross-functional collaboration.
• Excellent technical writing and presentation skills.

Responsibilities

• Initiate, revise, and approve manufacturing procedures.
• Assess process performance via floor observations and data.
• Provide troubleshooting support.
• Assist in training materials and delivery.
• Support establishment of process monitoring parameters and control limits.
• Prepare quarterly process-monitoring reports.
• Triages non-conformances and writes investigation reports.
• Execute corrective actions and NC/CAPA closure.
• Participate in regulatory inspections and NPI.
• Assist CCRB packaging for manufacturing changes.
• Participate in special projects and initiatives.

Skills

Bioprocessing

GMP

Cross-functional teams

Regulatory knowledge

Technical writing

Communication

Process optimization

Education

Doctorate

Master's + 2 years ManufacturingOps

Bachelor's + 4 years ManufacturingOps

Associates + 8 years ManufacturingOps

High school/GED + 10 years ManufacturingOps

Tools

TrackWise

SAP

Job description

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.

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

This role will serve as the External Supply Quality Record Owner, responsible for managing and executing supplier-related Change Control quality records with minimal supervision. The individual will lead cross-functional meetings to ensure the timely progression and closure of Change Control records. The ideal candidate should possess strong expertise in Change Control processes, demonstrated critical-thinking skills to assess supplier-related quality records, and hands-on experience with TrackWise and SAP. Effective communication, collaboration, and the ability to drive results across multiple stakeholders are essential for success in this role.

SUMMARY

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.

FUNCTIONS

Applied Process Expertise

• 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.

Process Monitoring

• 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.

Non-Conformance and CAPA

• 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.

Process Validation

• 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.

Regulatory

• 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.

Change Control

• Assist manufacturing change owner on CCRB packages impacting the process.

Projects and Initiatives

• Participate on the assessment or implementation of special projects or initiatives.

Other functions may be assigned.

EDUCATION/LICENSES

• Doctorate OR Master's + 2 years of Manufacturing Operations experience
• Bachelors + 4 years of Manufacturing Operations experience
• Associates + 8 years of Manufacturing Operations experience
• High school/GED + 10 years of Manufacturing Operations experience

COMPETENCIES/SKILLS

• 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.

*Weil Group is proud to be an Equal Employment Opportunity Employer.*