The Role
Support manufacturing and quality systems for pharma/biotech production: manage change controls, lead deviation/CAPA investigations, support process validation, campaign readiness, MBR/BOM revisions, training, troubleshooting, risk and microbial assessments, and drive process improvements.
Summary Generated by Built In
QUALITY CONSULTING GROUP, a leader in the 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:
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.
- Bachelor's degree in related 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
Skills Required
- Bachelor's degree in a related area
- Academic background in Engineering (Chemical, Mechanical, Industrial) or Biotechnology
- Hands-on engineering experience in manufacturing operations within a regulated environment (pharma/biotech)
- Familiarity with automation systems and process equipment
- Experience with continuous improvement methodologies (Lean Six Sigma, Kaizen) and root cause analysis
- Demonstrated ability to troubleshoot manufacturing issues and implement CAPA
- Knowledge of cGMP, regulatory compliance, and documentation practices
- Experience authoring investigation reports and presenting during regulatory inspections
- Ability to support MBR creation/revisions and assess BOM changes
- Willingness to work assigned administrative shift and perform on-floor support
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The Company
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
