Technical Operations Engineer

Role Summary

Technical Operations Engineer

Responsibilities

• Collaborate with technical services to identify and confirm Critical and Key Process Parameters essential for Equipment and Process Validation.
• Report team progress, highlight risks, clarify issues, suggest recommendations, and present next stage development plans.
• Operate various process equipment such as fermenters, recovery equipment, and depth filtration equipment, and coordinate daily activities of Good Manufacturing Practices (GxP) production to meet supply chain needs.
• Facilitate effective project meetings with internal team members and customers, and develop SPC charts for continuous process monitoring and control.
• Manage project finances, provide information to support financial reporting requirements, and ensure process adjustments are incorporated into final SOPs, Master Batch Records, and Compounding Records.
• Provide troubleshooting and technical support to manufacturing groups, participate in process and cleaning validations, adhere to site safety standards, and enforce safety and biosafety requirements in the manufacturing department.

Qualifications

• Required: Bachelor's degree with at least 2 years of experience; OR a Master's degree with 0+ years of experience; OR an Associate's degree with 6 years of experience; OR a High school diploma (or equivalent) and 8 years of relevant experience
• Demonstrated knowledge of Good Manufacturing Practices and experience in a pharmaceutical environment
• Proficiency in project-oriented admin, cost control, and management

Preferred Qualifications

• Experience in raw material validation and single use technology
• Knowledge of the manufacturing process and equipment, including filtration technology
• Experience in facilitating project meetings and managing project finances
• Commitment to safety and compliance with biosafety requirements

Physical / Mental Requirements

• Good leadership and communication abilities
• Strong technical management and organizational skills
• Strong problem-solving skills

Additional Requirements

• This role is standard office hours, Monday through Friday work schedule