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Specialist Manufacturing Juncos, PR, 35596

Integrated Services For Productivity & Validation, Inc

Job Location:

Juncos - Puerto Rico

Monthly Salary: Not provided by the employer

Experience Required: 4-5years

Posted: 30 July 2026 (30+ days ago)

Application Deadline: 27 October 2026

Vacancies: 1 Vacancy

Job Summary

Specific responsibilities include but are not limited to:

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 BOMs (Bill of Materials)

Serves as a peer-recognized specialist in at least one area with overall responsibility for determining methodologies in that area.

Requirements

Doctorate OR Masters 2 years of Manufacturing Operations experience

OR Bachelors 4 years of Manufacturing Operations experience

OR Associates 8 years of Manufacturing Operations experience

OR High school/GED 10 years of Manufacturing Operations experience

Shift: 8 hour shift Mon-Fri 8am-5pm (flexibility for on-call support at any time)

Preferred Qualifications:

Educational background in Life Sciences and/or Engineering.

In-depth experience of bio-processing unit operations (Cell Culture Drug Substance Purification)

Knowledge in Root Cause Analysis methodologies (Fishbone Six Boxes Fishbone 5 Whys Kepner Tregoe)

Familiar with Lean Manufacturing Practices

Ability to communicate and collaborate with technical and management staff within manufacturing process development and quality.

Proficiency in GDP (Good Documentation Practices) on a regulated environment

Knowledge in systems: Trackwise Spotfire CDOCS and process monitoring platforms

Strong Technical Writing/presentation abilities and excellent written/verbal communication skills in English and Spanish

Required Skills:

Specific responsibilities include but are not limited to: 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 BOMs (Bill of Materials) Serves as a peer-recognized specialist in at least one area with overall responsibility for determining methodologies in that area.

Required Education:

Doctorate OR Masters 2 years of Manufacturing Operations experience OR Bachelors 4 years of Manufacturing Operations experience OR Associates 8 years of Manufacturing Operations experience OR High school/GED 10 years of Manufacturing Operations experience Shift: 8 hour shift Mon-Fri 8am-5pm (flexibility for on-call support at any time) Preferred Qualifications: Educational background in Life Sciences and/or -depth experience of bio-processing unit ope

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