_{24th March, 2026}

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
• 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.

 
REQUIREMENTS
 

• 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.
• Experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems.
• Profficient and experienced in owning Change Controls.
• Project Management and/or Quality Management skills and experience. Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.
• Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
• Excellent communication skills, both written and verbal (including technical writing and presentation skills) in English, with ability to collaborate productively with technical and senior management staff.
• Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work and communicate effectively.
• Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
• Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook)
• Experience managing quality records (deviations, CAPAs, CAPA-EV, Change Controls, Supplier Investigation Records) using TrackWise, or Vevaa or a comparable quality system
• Experience navigating and executing transaction in SAP (ERP) system.
• Ability to tactfully negotiate and positively influence peers and executive leadership.
• Strong negotiation skills when working with external suppliers and internal team members.
• Ability to maintain remote working relationships with colleagues and network.

 

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