Principal Quality Engineer

Senior National Recruiter @ Planet Pharma | Talent Acquisition & Recruitment Specialist

Principal Quality Engineer needed!

Job Summary:

• Champions initiatives for identifying/developing criteria for procurement/installation of new Measurement and Test Equipment (M&TE) for laboratories with respect to testing standards.
• Responsible for design, writing, and executing non-routine qualifications, requalifications, process validations, and building validations for M&TE as required by appropriate industry regulations and standards (e.g., 21 CFR Part 820, ISO 17025).
• Analyze qualification, requalification and validation raw data and generate final reports.
• Collaborates with CSV and IT to complete GxP documentation, compliance, and validation of equipment that generates electronic data compliant with industry regulations and standards (e.g. 21 CFR Part 11).
• Investigate and troubleshoots using advanced mathematical and engineering knowledge.
• Write/implement quality records such as change control plans, risk assessments, nonconformance, corrective action and preventative action.
• Expertly applies technical aptitude for requalifying, conducting process validations and trouble‑shooting sterilizers and resistometers.
• Experienced driving purchasing process for materials/services needed for owning departments.
• Maintain and support equipment documentation in the Equipment Management System.
• Collaborates with departments to provide training to Associates for equipment use and processes.
• Drive proactive solutions when trending and analysis of TE failures observed.
• Expert installing, validating, troubleshooting, and maintaining continual monitoring points.
• Assists laboratory personnel with continuous monitoring and alarm investigations.
• Completes periodic review of Engineering owned software systems.
• Assists Engineering Management with additional department metrics/data gathering utilized in management review/support capital projects.
• Provide equipment records to appropriate staff as needed for client audits and dedicated qualification/validation SME where appropriate.
• Aligns with Engineering Management by mentoring teammates, prioritizing team tasks, and providing guidance.
• Apply standard engineering techniques to assist laboratories with proactive equipment planning.
• Ensure electronic and paper equipment files are retired/archived and when appropriate, disposed appropriately.
• Interfaces with groups within the organization on equipment and quality‑related issues.
• Assists updating procedures and training related to local and global engineering processes.
• Assist Engineering Management with harmonization of equipment, equipment processes and documentation to other sites to ensure global alignment.
• Assist Engineering Management with internal/external document review for revised industry regulations and standards

Qualifications & Technical

Competencies:

• Bachelor’s degree in engineering or related scientific discipline required; M.S. preferred.
• 8 to 10 years of related work experience in Engineering.
• Microsoft Word, Excel, and Project experience required.
• Expertly applies regulatory requirements to requirement specifications, system qualifications, validations, protocols, equipment operating procedures, standard operating procedures, and validation reports.
• Technical expert of Building Automation System.
• Strong written/verbal communication, organization, and time management skills.
• Able to excel both as part of a team and independently, with a focus on mentoring Engineering Associates.
• Demonstrates critical thinking skills to identify, design, configure, and complete validation process for Engineering software systems.
• Strong project management skills ensuring timely completion, within budget, coordinating with departments and vendors as needed.

$/yr - $/yr

• Annual Bonus
• Direct message the job poster from Planet Pharma

Not Applicable

Full-time

Engineering and Quality Assurance

Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

• Medical insurance
• Vision insurance
• 401(k)