Manufacturing Specialist (3610106)

Job Description

Job Description

Title : Specialist Manufacturing (3610106)

Location: Juncos, Puerto Rico (Open to Puerto Rico Residents)

Work Schedule: On-Site | Administrative Shift

Positions Available: 2

Contract Duration: 1 Year

Position Summary

Our client is seeking a Manufacturing Specialist to support manufacturing and quality operations within a highly regulated environment. Under minimal supervision, the selected candidate will support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training programs, and new product introductions (NPI).

The ideal candidate will apply scientific, operational, and compliance expertise to support manufacturing processes, troubleshoot operational issues, drive continuous improvement initiatives, and ensure compliance with GMP and regulatory requirements. This role may also serve as a primary process owner for designated systems and support ownership responsibilities for more complex manufacturing processes.

Preferred Qualifications

• Experience conducting deviation and non-conformance investigations.
• Strong technical writing and report development skills.
• Knowledge of root cause analysis methodologies, including:
• 5 Whys
• Causal Factors Analysis
• Other structured problem-solving tools
• Project management skills, including action tracking, prioritization, and meeting established deadlines.
• Experience working in GMP-regulated manufacturing environments.

Essential Responsibilities

Applied Process Expertise

• Initiate, revise, review, and approve manufacturing procedures and related documentation.
• Ensure procedures accurately reflect current manufacturing operations and serve as a document owner when assigned.
• Evaluate process performance through floor observations, data analysis, and performance metrics.
• Identify, assess, and implement process improvement opportunities.
• Provide technical troubleshooting and manufacturing support.
• Assist in the development of training materials and deliver training on scientific and technical process-related topics.

Process Monitoring

• Support the establishment of process monitoring parameters and control limits.
• Collect and analyze process monitoring data.
• Support investigations related to process deviations.
• Assist in the preparation and timely completion of quarterly process monitoring reports.

Non-Conformance Management and CAPA

• Ensure non-conformances are triaged within established timelines.
• Author and support investigation reports.
• Execute and track corrective and preventive actions (CAPAs).
• Manage non-conformance and CAPA closure activities to meet established goals.
• Monitor and communicate incident and deviation trends.
• Review Root Cause Analysis (RCA) investigations for equipment and systems.
• Support trend analysis and continuous improvement initiatives.

Process Validation

• Assist in the development of process validation protocols and reports.
• Support process validation execution activities.
• Collect, analyze, and interpret validation data.
• Ensure validation activities are properly documented and compliant with regulatory requirements.

Regulatory Compliance

• Participate in regulatory inspections and audit readiness activities.
• Support New Product Introductions (NPI).
• Assist with process and equipment modification initiatives.
• Assess documentation, materials, training requirements, and equipment impacts associated with new products and process changes.

Change Control

• Support manufacturing change owners with Change Control Review Board (CCRB) packages impacting manufacturing processes.
• Assist with change implementation and documentation activities.

Projects and Continuous Improvement

• Participate in special projects and operational initiatives.
• Support cross-functional efforts focused on process optimization, compliance enhancement, and operational excellence.
• Perform additional duties as assigned.

Education and Experience Requirements

Candidates must meet one of the following qualifications:

• Doctorate Degree, OR
• Master’s Degree with a minimum of 2 years of manufacturing operations experience, OR
• Bachelor’s Degree with a minimum of 4 years of manufacturing operations experience, OR
• Associate Degree with a minimum of 8 years of manufacturing operations experience, OR
• High School Diploma/GED with a minimum of 10 years of manufacturing operations experience.

Required Competencies and Skills

• Strong technical knowledge of bioprocessing unit operations.
• Experience performing GMP manufacturing operations.
• Understanding of regulatory requirements and regulatory interactions.
• Ability to participate in and support cross-functional teams.
• Strong collaboration and communication skills with Manufacturing, Process Development, Engineering, and Quality organizations.
• Excellent organizational, technical writing, and presentation skills.
• Basic project management skills.
• Working knowledge of statistical process monitoring and control charting.
• Strong analytical, troubleshooting, and problem-solving capabilities.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.