Description
Essential:- Develop and recommend near-term and long-term strategies for GMP drug product manufacture, potentially also contract filling capability.
- Plan, manage, organize engineering tasks and capital expenditures consistent with company and industry standards, as well as regulatory guidance for biopharmaceutical sterile product filling.
- Manage and review filling equipment and support systems design specifications, performance, calibration, maintenance, and validation requirements.
- Plan and support facility projects for installation and operation.
- Oversee project timelines for equipment procurement, fabrication, delivery, qualification and training.
- Manage internal and external resources to assist with project execution as necessary.
- Organize, plan, and manage contract filling projects.
Education and Experience:
- Bachelors degree in a related Engineering field.
- 5+ years industry experience in GMP bio/pharmaceutical aseptic filling operations.
- Knowledge and experience working with major global vendors and regulatory agencies.
- Management of capital projects and budgets.
Knowledge, skills and abilities:
- Demonstrated teamwork, communication and leadership skills; ability to influence across functions and organizations.
- Project management and technical writing skills
- Team player with a can-do attitude, the ability to analyze complex problems and identify creative solutions.
Key skill and experiences:
Chemical Engineering
Engineering
Manufacturing/Production
Operations
Process Development
Technical Services
Please send me your CV and I will follow up with you.
To find out more about Real Staffing please visit www.realstaffing.com