Bioprocess Manufacturing Specialist: GMP & Process Owner

Kelly Services; Juncos (PR); On-site; USD 85,000 - 130,000; Full time

Job summary

Kelly Services is seeking a highly skilled bioprocess operations professional to support manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions.

With minimal supervision, you will apply process and analytical expertise, contribute to addressing performance gaps, and may serve as the primary production process owner for process support systems, collaborating with cross-functional teams and management to drive

Qualifications

• 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.

Responsibilities

• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Provide troubleshooting support.
• Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.

Skills

Bioprocessing

GMP operations

Regulatory knowledge

Cross-functional teams

Communication & collaboration

Technical writing

Project management

Control charts

Education

Doctorate

Master's + 2 years of Manufacturing Operations experience

Bachelor's + 4 years of Manufacturing Operations experience

Associates + 8 years of Manufacturing Operations experience

High school/GED + 10 years of Manufacturing Operations experience

Job description

Kelly Services is seeking a highly skilled bioprocess operations professional to support manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions.

With minimal supervision, you will apply process and analytical expertise, contribute to addressing performance gaps, and may serve as the primary production process owner for process support systems, collaborating with cross-functional teams and management to drive