Specialist - DS Manufacturing Programs

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 89,000 - 134,000; Full time

Job summary

BioPharma Consulting JAD Group seeks an experienced professional to support manufacturing and quality systems and act as a document owner for procedures and validation studies. This role involves troubleshooting, data analysis, and cross‑functional collaboration across manufacturing, process development, and quality teams.

Responsibilities include generating training materials, monitoring process performance, and assisting with regulatory inspections and NPIs.

Qualifications

• PhD or relevant advanced degree with manufacturing operations experience.
• Experience with bioprocessing unit operations and Lean practices.
• Excellent communication in English and Spanish; ability to lead cross-functional teams.

Responsibilities

• Support execution of manufacturing and quality systems (NCRs, CAPAs, process validation).
• Assist in creating and revising procedures; own documents.
• Provide troubleshooting and data-driven process improvements.
• Assist in training materials and training delivery.
• Support process monitoring parameters and control limits.
• Collect data for process validation and deviation assessments.
• Participate in regulatory inspections and NPIs as needed.

Skills

Bioprocessing

GMP production

Regulatory knowledge

Cross-functional teams

Communication

Project management

Control charting

Education

Doctorate

Master’s + 2 years Manufacturing Operations

Bachelor’s + 4 years Manufacturing Operations

Associate’s + 8 years Manufacturing Operations

High School/GED + 10 years Manufacturing Operations

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.