Planet Pharma · 2 hours ago
Engineer Senior
New Albany, OH
Full-time
Onsite
Mid, Senior Level
$38/hr - $48/hr
2+ years expPlanet Pharma is a company focused on biotech and pharmaceutical manufacturing. They are seeking a Senior Engineer to organize Technology Transfer activities for Final Drug Product manufacturing, supporting project schedules, leading site assessments, and working across global teams.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Organize Technology Transfer activities for Final Drug Product (FDP) manufacturing
Support and create project schedules
Lead site assessment and manufacturing capabilities
Update project dashboards
Lead team meetings to progress the project towards final objectives
Work across a global, cross-functional team consisting of manufacturing, device and packaging design for combination products, capital projects, physical test methods, quality, and regulatory team members
Focus on leading effective Tech Transfer projects for combination products, enhancing end-to-end controls with robust methods and data flow in a GMP setting
Support New Product Introduction to the manufacturing site
Own documentation such as Project Plan, supporting engineering with Process Transfer Documents (PTD), protocols, and reports
Support engineers with Make-a-Batch (M-a-B) activities to ensure sending/receiving site expectations are met
Develop, track, and provide project dashboard updates
Provide good communication plans to cross-functional teams and Process Engineer management
Apply project management and engineering science to production
Demonstrate strong teamwork and excellent interpersonal and communication skills
Qualification
Required
Master's degree
OR Bachelor's degree and 2 years of experience
OR Associate's degree and 6 years of experience
OR High school diploma/GED and 8 years of experience
Experience: Biotech and pharma, GMP environment, manufacturing and tech transfer background, combination products
Skills: Strong English written and verbal communication skills, MS Office, SmartSheet (project scheduling software), project management experience in a supporting role
Ability to apply project management and engineering science to production
Strong teamwork and excellent interpersonal and communication skills
Preferred
Experience in the Tech Transfer of Combination Product field, focusing on project management and/or manufacturing
Understanding of interdependencies of complex projects, especially involving new product introductions with new equipment/processes
Knowledge of Combination Product design controls and regulatory requirements on a global scale
Familiarity with the company's commercialization framework
Program and Project Management skills (experience with MS Project, SmartSheets, and other project scheduling software is desired)
Proactive risk assessment, management, and mitigation
Ability to lead and succeed in an ambiguous environment
Strong project management skills
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