Planet Pharma · 1 week ago
Manufacturing Engineer
Austin, TX
Full-time
Onsite
Mid Level
$35/hr - $45/hr
4+ years expPlanet Pharma is a part of the U.S. Orthopedics Operations Engineering team, seeking a Manufacturing Engineer to lead manufacturing transfers across their global network. The role involves coordinating technical readiness, validation activities, and ensuring compliance with quality and safety standards during transitions between manufacturing sites.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Execute end-to-end manufacturing and site transfer projects, including planning, risk assessment, validation, and handover
Coordinate all technical documentation, process flows, and equipment readiness activities at both sending and receiving sites
Support process and equipment validation (IQ/OQ/PQ) and ensure compliance with FDA and ISO 13485 requirements
Partner cross-functionally with Quality, Regulatory, Supply Chain, Manufacturing, and R&D to ensure alignment and readiness
Lead root cause analysis and technical problem-solving throughout the transfer lifecycle
Prepare and maintain project documentation, including validation protocols, reports, and change control packages
Communicate project progress, risks, and mitigation strategies to stakeholders at all levels
Capture and share lessons learned to continuously improve future transfer processes
Qualification
Required
Bachelor's degree in engineering, science, or related discipline
Minimum of 4 years of experience in medical device manufacturing or other regulated industries
Proven track record leading or supporting site or manufacturing transfers
Or, proven track record of new product launches into existing sites
Strong knowledge of process validation, change control, and manufacturing documentation
Excellent problem-solving, communication, and organizational skills
Ability to work independently and drive results with minimal supervision
Preferred
Experience with orthopedic implants, instruments, or precision assembly
Familiarity with lean manufacturing and Six Sigma methodologies
Proficiency with ERP, PLM, or MES systems
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