Specialist Manufacturing - Juncos, PR, 35596

Integrated Services for Productivity & Validation, Inc; Juncos (PR); On-site; USD 90,000 - 110,000; Full time

Job summary

Integrated Services For Productivity & Validation, Inc in Juncos, Puerto Rico, is seeking a Manufacturing Operations Specialist who will own change controls, support investigations, and drive process improvements in a regulated environment. The role requires advanced degrees or substantial experience in manufacturing operations and emphasizes cross-functional collaboration, technical writing, and proficiency with Trackwise and Spotfire.

Shift is 8 hours, Mon-Fri; on-site work.

Qualifications

• Doctorate or Master’s plus 2 years of Manufacturing Operations experience.
• OR Bachelor’s plus 4 years of Manufacturing Operations experience.
• OR Associate plus 8 years of Manufacturing Operations experience.
• OR High school/GED plus 10 years of Manufacturing Operations experience.

Responsibilities

• Own change controls for manufacturing process changes.
• Support major/trend deviation investigations across lifecycle including Root Cause Analysis, CAPA, and regulatory presentations.
• Support risk assessments and microbial assessment evaluations.
• Lead commercial campaign readiness and collaborate with cross-functional areas.
• Assist in generating training materials and providing training on process topics.
• Provide on-floor troubleshooting and GDP-compliant documentation.
• Design, coordinate and support functional tests and water tests during major changes.
• Assist in Master Batch Record creation/revisions.
• Assess and implement process improvements and equipment changes.
• Create and approve standard manufacturing procedures; serve as document owner.

Skills

Manufacturing operations

Root cause analysis

Lean manufacturing

Technical writing

Regulatory compliance

Cross-functional collaboration

Bilingual English/Spanish

Process development

Education

Doctorate

Master's degree

Bachelor's degree

Associate degree

High school diploma

Tools

Trackwise

Spotfire

CDOCS

Process monitoring platforms

Job description

Integrated Services For Productivity & Validation, Inc | Contract

Juncos, Puerto Rico | Posted on 07/29/2026

We provide the industry with a platform of solutions designed to their actual needs. We share and implement leading edge technology and methods that exceed customer expectation and deliver a one-stop provider of services focus on the well-being of the company and the employees.

Job Description

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 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.

Requirements

Doctorate OR Master's + 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 Why's, 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