Description:
Staff Project Engineer - Space Planning Focus
On-site
1. Education:
Minimum: A bachelor's degree from an accredited university in an engineering, engineering technology or architecture.
2. Experience:
10+ years of experience working in cGMP manufacturing environment, preferably in a project management or engineering role. Experience working on various stages across the project lifecycle including initiation, planning, implementation, closeout. Experience in space planning laboratories and pharmaceutical manufacturing facilities is a plus.
3. Technical Skills:
Proficiency in managing and leading projects with limited oversight, including building fit-out projects and technical transfers.
Experience in leading and coordinating cross-functional teams, including architects, engineers, planners, construction managers, stakeholders, end users, and support functions.
Experience in implementing projects in a phased approach in active manufacturing areas.
Strong technical expertise in pharmaceutical facilities design and construction with an emphasis on clean utilities and cleanrooms up to ISO 7. Experience with biotechnology and/or cell and gene therapies is a plus.
Strong leadership and communication skills are necessary to guide and mentor project teams effectively. This includes the ability to provide strategic direction, make critical decisions, and collaborate with stakeholders at various levels of the organization.
Ability to work independently with little direction from senior members of the team.
Strong experience with space planning laboratories and manufacturing spaces, including producing layouts in CAD. Experience should include programming discussions with end users, understanding utility considerations for equipment, and driving decisions with end users.
4. Quality Mindset:
A strong commitment to quality and compliance, with an understanding of quality systems and continuous improvement concepts like Lean Six Sigma.
5. Communication:
Excellent written and verbal communication skills are important in this role. The ability to present project updates, findings, and proposals to both technical and non-technical audiences. The ability to effectively communicate complex scientific concepts to a diverse audience is crucial.
6. Regulatory Compliance:
Familiarity with regulatory requirements specific to cell and gene therapies, such as those from the Food and Drug Administration (FDA), European Medicines Agency (EMA), and other relevant regulatory bodies, is necessary. This includes an understanding of current guidelines and regulations.
7. Problem-Solving:
Strong problem-solving and critical-thinking skills to effectively tackle complex challenges in the development and manufacturing of cell and gene therapies. The ability to identify potential issues, develop contingency plans, and drive innovative solutions is vital.
Hours:
Hours per Day: 7.5
Hours per Week: 37.5
Total Hours: 2,385.00
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