Specialist - DS Manufacturing Programs

Biopharma-Consulting-Jad-Group; Juncos (PR); On-site; USD 60,000 - 85,000; Part time

Job summary

Biopharma-Consulting-Jad-Group in Juncos, Puerto Rico, seeks a Manufacturing Operations Support professional to execute and improve GMP manufacturing and quality systems under minimal supervision. You will handle non-conformances, validations, and change control, and may lead process support systems as primary owner.

The role requires strong bioprocessing knowledge, regulatory familiarity, and ability to work cross-functionally with quality, process development, and manufacturing teams.

Qualifications

• Detailed technical understanding of bioprocessing unit operations.
• Skilled in GMP production operations.
• Regulatory knowledge and interactions.
• Ability to participate in and help lead cross‑functional teams.
• Strong communication and collaboration skills with manufacturing, process development, and quality teams.
• Organizational, technical writing, and presentation skills.
• Basic project management skills.
• Basic knowledge of control charting.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; ensure all procedures reflect current operations.
• Assess process performance through inspections and data review; implement improvements.
• Provide troubleshooting support.
• Assist in generating training materials and training.
• Support establishment of process monitoring parameters and control limits.
• Collect process‑monitoring data and support deviation assessments.
• Support timely execution of quarterly process monitoring reports.
• Manage NC/CAPA closure within established timelines.
• Author investigation reports and execute corrective actions.
• May participate in regulatory inspections, NPI, and process or equipment modifications.
• Assess, prioritize, justify, and provide implementation and project management support for modifications.
• Assist manufacturing change owners with CCRB packages impacting the process.
• Participate in special projects or initiatives as assigned.

Skills

Bioprocessing

GMP operations

Regulatory knowledge

Cross-functional leadership

Communication

Project management

Technical writing

English

Spanish

Documentation

Root Cause Analysis

Education

Doctorate

Master’s

Bachelor’s

Associate’s

High School/GED

Tools

TrackWise

VEEVA

MES

Smartsheet

ChatGPT

Copilot

Power BI

Spotfire

CDOCS

Job description

With minimal supervision, supports the execution of manufacturing and quality systems such as non‑conformances, process validation, procedures, training, and new product introductions. Applies process, operational, and scientific expertise, basic compliance knowledge, and analytical/troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities for more complex process systems.

Functions

• Initiate, revise, and approve manufacturing procedures; ensure all procedures reflect current operations. Serve as document owner.
• Assess process performance through floor observation and review of performance data; evaluate, plan, and implement solutions for process improvement opportunities.
• Provide troubleshooting support.
• Assist in generating training materials and may support training on scientific or technical aspects of the process.
• Support establishment of process monitoring parameters and control limits.
• Collect process‑monitoring data and support deviation assessments.
• Support timely execution of quarterly process monitoring reports.
• Ensure all non‑conformances are triaged within established goals.
• Author investigation reports.
• Execute corrective actions.
• Manage NC/CAPA closure within established timelines.
• Monitor and communicate incident trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• Assist in generating process validation protocols and reports.
• Support execution of process validation activities.
• Support collection and analysis of process validation data.
• May participate in regulatory inspections, New Product Introductions (NPI), and process or equipment modifications.
• Participate in NPI assessments for documentation, materials, training, and equipment modification requirements.
• Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
• Assist manufacturing change owners with CCRB packages impacting the process.
• Participate in the assessment or implementation of special projects or initiatives.
• Other functions may be assigned.

Skills

• Detailed technical understanding of bioprocessing unit operations.
• Skilled in GMP production operations.
• Regulatory knowledge and interactions.
• Ability to participate in and help lead cross‑functional teams.
• Strong communication and collaboration skills with manufacturing, process development, and quality teams.
• Organizational, technical writing, and presentation skills.
• Basic project management skills.
• Basic knowledge of control charting.

• Doctorate OR

• Master’s + 2 years of Manufacturing Operations experience OR
• Bachelor’s + 4 years of Manufacturing Operations experience OR
• Associate’s + 8 years of Manufacturing Operations experience OR
• High School/GED + 10 years of Manufacturing Operations experience.

Preferred Qualifications

• Experience with bioprocessing unit operations.
• Knowledge of Root Cause Analysis methodologies (Fishbone, Six Boxes, 5 Why’s, Kepner‑Tregoe).
• Familiarity with Lean Manufacturing practices.
• Strong communication and collaboration skills across manufacturing, process development, and quality.
• Proficiency in GDP within a regulated environment.
• Knowledge of systems/tools: TrackWise, VEEVA, MES, Smartsheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms.
• Strong technical writing and presentation abilities; excellent written and verbal communication skills in English and Spanish.
• Team‑oriented mindset.
• Ability to work under minimal supervision and/or high workload and pressure.
• Ability to work extended hours.
• Excellent interpersonal skills.

• 6-month contract with possible extension
• Monday–Friday | 8:00 AM – 5:00 PM

• Overtime may be requested based on business needs.