Specialist Manufacturing

ECHO Consulting Group Inc; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

ECHO Consulting Group, Inc. in Juncos, PR is seeking a Manufacturing Operations Specialist to support the execution of quality systems, non-conformances, process validation, procedures, training, and new product introductions with minimal supervision.

The role applies process, operational, scientific expertise, and analytical skills to support manufacturing. You may lead cross-functional efforts on change control, CAPA, and regulatory interactions, driving improvements and ensuring compliant,

Qualifications

• Advanced degree requirement includes multiple combinations with manufacturing ops experience.
• Experience in GMP manufacturing and regulatory environments is required.
• Proven ability to lead cross-functional teams and manage documentation.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; maintain current operation documents.
• Monitor process performance and implement improvement opportunities.
• Provide troubleshooting support and train staff on processes.
• Generate training materials and deliver technical training as needed.
• Support process validation, CAPA, and regulatory inspections when required.

Skills

Bioprocessing operations

GMP production operations

Regulatory knowledge

Cross-functional collaboration

Communication and documentation

Project management basics

Control charts

Education

Doctorate or Master’s with 3+ years manufacturing ops or Bachelor’s with 5+ years or Associate’s with 10 years or High school with 12 years

Tools

TrackWise

SAP

Job description

ECHO Consulting Group is a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management. We are committed to offering exciting career opportunities in a workplace that values trust, respect, teamwork, creative talent, enthusiasm, and diligence. We are looking for talented professionals who are passionate about quality, collaboration, and delivering results. We believe great talent deserves great rewards. That’s why we offer a competitive compensation package and professional development.

Summary of Role:

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.

Responsibilities

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 & 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.

Shift

Administrative

Location

Juncos, PR

Education

Doctorate degree OR Master's degree and 3 years of Manufacturing Operations experience OR Bachelor's degree and 5 years of Manufacturing Operations experience or Associate’s degree and 10 years of Manufacturing Operations experience or High school diploma / GED and 12 years of Manufacturing Operations experience.

Preferred Qualifications

• 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.

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.

Equal Employment Opportunity

ECHO Consulting Group, Inc. is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law. We assure you that your opportunity for employment with ECHO Consulting Group, Inc. depends solely on your qualifications.