What are the responsibilities and job description for the Commissioning Specialist position at Fusion Life Sciences Technologies LLC?
Job Title: Project Engineer/Manager - Pharma Equipment Installations
Location: Athens, GA
Job Summary: We are seeking a highly skilled and experienced Project Engineer/Manager to join our team, specializing in pharmaceutical equipment installations. The ideal candidate will have a strong background in the installation, qualification, and validation of large-scale equipment, such as dryers and centrifuges, within the pharmaceutical industry.
Key Responsibilities:
- Lead and manage end-to-end pharma projects involving the installation, qualification, and validation of large equipment, including dryers and centrifuges.
- Develop detailed project plans, including scope, timeline, resource allocation, and budget.
- Coordinate with internal and external stakeholders to ensure smooth execution of the project lifecycle.
- Ensure adherence to GMP, industry standards, and regulatory requirements during all phases of the project.
- Oversee the installation, commissioning, and validation processes, ensuring equipment meets quality and operational standards.
- Lead troubleshooting and problem-solving efforts during the equipment installation and commissioning phases.
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or related field (Master’s degree preferred).
- 10 years of experience in project engineering or project management within the pharmaceutical industry, specifically in equipment installation and validation.
- Proven experience with large-scale equipment such as dryers, centrifuges, and similar pharmaceutical machinery.
- Expertise in project management, including planning, risk management, budgeting, and scheduling.
- Strong knowledge of GMP, FDA regulations, and ISO standards related to pharmaceutical equipment installation and validation.
- Hands-on experience with both the installation and qualification/validation of equipment.
- Ability to manage complex projects with multiple stakeholders, meeting deadlines and budgets.
- Excellent problem-solving skills and ability to work under pressure.
- Strong communication, leadership, and interpersonal skills.
- Experience in direct hire roles and long-term engagement with companies throughout the entire project lifecycle.
- Ability to travel as required by the project.
Preferred Skills/Experience:
- Experience in the pharma industry with direct hire experience, having worked for the companies you did projects for and seeing the entire process through to the end.
- Proficiency with project management tools and software (e.g., Microsoft Project, Primavera, etc.)
