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Specialist Manufacturing 2966659

Specialist Manufacturing Opportunity

Title: Specialist Manufacturing (Job ID: 2966659)

Location: Juncos, PR (Open to U.S. Citizens residing in Puerto Rico)

Work Schedule: 100% Onsite, 8:00 AM – 5:00 PM (8-hour shift)

Positions Available: 1

Duration: Approximately 8 months


Summary

Join our client’s team as a Specialist Manufacturing, where you will support the execution of manufacturing and quality systems with minimal supervision. In this role, you’ll manage non-conformances, process validations, procedures, training, and new product introductions. You will leverage your process expertise, operational knowledge, and compliance understanding to support manufacturing operations effectively.


As a key contributor, you may serve as the primary production process owner for various support systems, as well as assist with more complex process systems when necessary.


Educational and Experience Requirements

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


Preferred Qualifications

  • Proficiency in Veeva, Trackwise, CAPA, and Change Control systems.


Key Responsibilities

1. Applied Process Expertise

  • Initiate, revise, and approve manufacturing procedures, ensuring alignment with current operations.
  • Assess process performance through observation and data analysis; identify and implement process improvement opportunities.
  • Provide troubleshooting support.
  • Assist in the creation and delivery of training materials related to scientific or technical processes.


2. Process Monitoring

  • Establish process monitoring parameters and control limits.
  • Collect and evaluate process-monitoring data and deviations.
  • Support the timely completion of quarterly process monitoring reports.


3. Non-Conformance and CAPA Management

  • Triage non-conformances within defined timelines.
  • Author investigation reports and execute corrective actions.
  • Manage NC/CAPA closures and communicate incident trends.
  • Support Root Cause Analysis and trend evaluations for equipment/systems.


4. Process Validation

  • Assist in drafting and executing process validation protocols and reports.
  • Collect and analyze validation data to ensure compliance.


5. Regulatory Compliance

  • Participate in regulatory inspections as required.


6. New Product Introductions & Process/Equipment Modifications

  • Evaluate documentation, materials, training, and equipment needs for new product introductions (NPIs).
  • Provide project management support for process or equipment modification initiatives.


7. Change Control Management

  • Assist with CCRB packages impacting manufacturing processes.


8. Projects and Initiatives

  • Participate in special projects or initiatives as assigned.


Competencies and Skills

  • Strong technical understanding of bioprocessing unit operations.
  • Proficiency in GMP production operations.
  • Familiarity with regulatory compliance and inspection processes.
  • Team collaboration and leadership abilities in cross-functional environments.
  • Exceptional communication, organizational, and technical writing skills.
  • Basic project management expertise and control charting knowledge.


Why Apply?

This is an excellent opportunity to contribute to a cutting-edge manufacturing environment while expanding your expertise in a dynamic and impactful role.

📢 Submit your updated resume today inside job description.


We look forward to reviewing your application!





Thank you. We will be in contact soon.

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