Planet Pharma ยท 1 day ago
Principal Quality Engineer
Marietta, GA
Full-time
Onsite
Lead/Staff
$100K/yr - $110K/yr
8+ years expPlanet Pharma is seeking a Principal Quality Engineer to champion initiatives for the procurement and installation of Measurement and Test Equipment for laboratories. The role involves designing and executing qualifications, collaborating with IT for compliance documentation, and mentoring teammates in engineering processes.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Valerie Meissner
Responsibilities
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
Qualification
Required
Bachelor's degree in engineering or related scientific discipline required
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
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
Preferred
M.S. preferred
Technical expert of Building Automation System
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase