Specialist Manufacturing
On-siteJuncos, Juncos, Puerto Rico
Job Summary
Initiate, revise, and approve manufacturing procedures while serving as the document owner to ensure they reflect current operations. Assess floor performance and implement solutions for process improvement, providing troubleshooting support and generating training materials. Support the establishment of process monitoring parameters, collect data, and execute quarterly reports. Manage non-conformances by triaging incidents, authoring investigation reports, and executing corrective actions to ensure closure within established goals. Assist with process validation protocols, data collection, and regulatory inspections for new product introductions and equipment modifications. Participate in cross-functional teams to assess special projects and implement change control packages impacting the process.
Required Qualifications
- 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
- 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, and excellent written/verbal communication skills in English and Spanish
- Able to work under minimal supervision and/or high workload and pressure
- Able to work extended hours
- Excellent interpersonal skills
- Detailed technical understanding of bioprocessing unit operations
- Skilled in performance of GMP production operations
- Regulatory knowledge and interactions
- Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
- 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 -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
Desired Qualifications
- 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, and 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
- Detailed technical understanding of bioprocessing unit operations
- Skilled in performance of GMP production operations
- Regulatory knowledge and interactions
- Participate and help lead cross-functional teams
- Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
- Organizational, technical writing and presentation skills
- Basic project management skills
- Basic knowledge of control charting
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