JT601 - SPECIALIST MANUFACTURING

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

QUALITY CONSULTING GROUP, LLC is seeking a talented, highly motivated manufacturing quality engineer to join our team in Puerto Rico/USA. The role focuses on supporting manufacturing and quality systems within regulated environments.

You will work with cross-functional teams to drive process improvements, CAPA actions, and document control while ensuring compliance with cGMP standards and regulatory expectations.

Qualifications

• Bachelor's degree in a related engineering field.
• Hands-on manufacturing operations experience in regulated environments (biotech/pharma).
• Familiarity with automation, process equipment, and continuous improvement methods.

Responsibilities

• Support the execution of manufacturing/quality systems (non-conformances, process validation, procedures, training, and new product introductions).
• Apply process knowledge to support manufacturing operations and troubleshoot issues.
• Own change controls for manufacturing process changes and support investigations (CAPA, root cause).
• Lead risk assessments and microbial assessment evaluations as needed.
• Assist in generation of training materials and provide on-floor training.
• Design, coordinate, and support functional tests and protocol generation.

Skills

Engineering experience

Automation systems

Process equipment

Lean Six Sigma

Kaizen

Root cause analysis

Problem solving

CAPA

Process optimization

Cross-functional collaboration

GMP knowledge

Communication

Adaptability

Shift flexibility

Education

Bachelor's degree in related area (Engineering preferred: Chemical, Mechanical, Industrial, or Biotechnology)

Job description

QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing to a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• 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.
• 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.
  

Qualifications:

• Bachelor's degree inrelated area (Preferred: Academic background in Engineering disciplines, particularly Chemical Engineering, Mechanical Engineering, Industrial Engineering, or Biotechnology.)
• Engineering Experience in Manufacturing Operations - Hands-on experience in process engineering, manufacturing support, or production systems within a regulated environment (biotech, pharmaceutical, or similar).
• Technical Knowledge - Familiarity with automation systems, process equipment, and continuous improvement methodologies (Lean Six Sigma, Kaizen, root cause analysis).
• Problem-Solving Skills - Demonstrated ability to troubleshoot manufacturing issues, implement corrective/preventive actions (CAPA), and drive process optimization.
• Cross-Functional Collaboration - Proven experience working with operations, quality, and maintenance teams to deliver results in a fast-paced environment.
• Regulatory / GMP Knowledge - Understanding of cGMP, compliance, and documentation practices for regulated industries.
• Additional Strengths - Strong communication, adaptability to change
• Administrative Shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.