Specialist Manufacturing 35451

Inteldot • Juncos, PR

8d • Onsite

About The Position

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

Requirements

• Experience of bio-processing unit operations
• 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/Tools: Trackwise, VEEVA, MES, Smart Sheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms
• Strong Technical Writing/presentation abilities
• Excellent written/verbal communication skills in English and Spanish
• Teamwork Oriented
• Able to work under minimal supervision and/or high workload and pressure
• Able to work extended hours
• Excellent interpersonal skills

Nice To Haves

• Preferred academic background in Life Sciences, Engineering, Biotechnology, Chemistry, and/or Engineering

Responsibilities

• Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions.
• Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
• Serve as primary production process owner for process support systems.
• Assist with process ownership responsibilities on more complex process systems.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED