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Specialist Manufacturing
Juncos, PR, US
Scientific
Bachelors Degree
Full Time, Temporary
38
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Juncos, PR, US
38
Experienced (Non-Manager)
Full Time, Temporary
Biotechnology/Pharmaceuticals
On-site
Scientific
Bachelors Degree
First Shift (Day)
Job details
SUMMARY
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.
FUNCTIONS
Applied Process Expertise
1. Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
2. Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
3. Provide troubleshooting support.
4. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
EDUCATION
-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.
COMPETENCIES/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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