Process Engineer II: CQV, Validation & Process Improvement

BioSpace; Petersburg (VA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Process Engineer to provide technical expertise in engineering processes and ensure compliance during regulatory inspections. The role requires a Bachelor's degree in Engineering and strong problem-solving abilities. Candidates should have 5+ years of experience in sterile injectables or biologics, demonstrating capability in managing multiple complex assignments in a fast-paced environment. The position involves leading cross-functional teams while focusing on continuous improvement and ensuring project goals are met efficiently.

Qualifications

• Bachelors degree in Engineering required.
• Strong mechanical aptitude.
• Demonstrated ability to solve technical problems and implement projects.
• Excellent interpersonal and communication skills, and fluency in English.
• Self-directed with effective analytical and problem-solving skills.

Responsibilities

• Provide technical expertise on CQV activities and ensures compliance to regulatory requirements.
• Participate in the Engineering process to develop and institute technical and procedural controls.
• Accountable for CQV activity for assigned systems, including all phases.
• Lead and participate in cross-functional groups to investigate and resolve technical issues.

Skills

Technical expertise in Engineering processes

Problem-solving skills

Interpersonal and communication skills

Mechanical aptitude

Education

Bachelor's degree in Engineering

Tools

DMAIC

FMEA

Job description

A leading biopharmaceutical company is seeking a Process Engineer to provide technical expertise in engineering processes and ensure compliance during regulatory inspections. The role requires a Bachelor's degree in Engineering and strong problem-solving abilities. Candidates should have 5+ years of experience in sterile injectables or biologics, demonstrating capability in managing multiple complex assignments in a fast-paced environment. The position involves leading cross-functional teams while focusing on continuous improvement and ensuring project goals are met efficiently.