Specialist Manufacturing

Echo-Consulting-Group; Puerto Rico; On-site; USD 85,000 - 120,000; Full time

Job summary

ECHO Consulting Group is seeking a Manufacturing Operations professional to support GMP production, document control, and process validation in a regulated setting. You will work with cross-functional teams to drive process improvements and ensure adherence to quality systems.

Responsibilities include procedure management, non-conformance handling, CAPA execution, and training support. Strong writing, analytical, and project skills are essential for success in this on-site role in Juncos, PR.

Qualifications

• PhD or MS with relevant manufacturing operations experience required.
• Alternative: Bachelor's with significant manufacturing operations experience.
• Additional path: Associate's with extensive operations background or high school diploma with long experience.

Responsibilities

• Initiate, revise, and approve manufacturing procedures and own documents.
• Assess process performance and implement optimization solutions.
• Provide troubleshooting support for process issues.
• Assist in training material development and execution on scientific/technical topics.
• Support establishment of process monitoring parameters and quarterly reports.
• Triages non-conformances and supports CAPA and root-cause analysis.
• Assist in generation of process validation protocols and reports.
• May participate in regulatory inspections and NPI activities.

Skills

Bioprocessing knowledge

GMP production operations

Regulatory knowledge

Cross-functional teamwork

Communication

Technical writing

Project management basics

Control charting basics

Education

Doctorate or Master's in related field with manufacturing ops experience

Bachelor's degree with manufacturing ops experience

Associate’s degree with manufacturing ops experience

High school diploma/GED with extensive manufacturing ops exp

Tools

Veeva Vault (CDOCs)

Smartsheet

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:

• Knowledge in document handling on Veeva Vault (CDOCs) or similar platforms

• Technical writing expertise

• Change control handling (owner)

• Project handling

• Use of Smartsheet or similar platform
  

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.