Project Engineer (closed)
This position provides both technical engineering services and manages complex capital and new product development projects. Required experience is cross functional and includes pharmaceutical drug (compressed gas, parental products) and device Engineering, Business Development, R&D / new product commercialization, Quality Assurance, Risk Management, Regulatory Affairs, HSE and Maintenance.
The position requires a self-starter with solid engineering expertise ranging from product/process conception thru post commercialization activities and sustainment. The position will provide technical and project management support which includes establishment of policies, SOPs, best practices, interdepartmental needs assessment and inclusion, team selection, project scoping, project tracking, leading status meetings, risk assessment, evaluating and reporting project progress, conflict resolution and post project reviews.
1) Manage capital projects assigned including identifying customer requirements, developing project scope, project plans, developing schedules and budgets to execute and complete projects on time, on budget and within safety & cGMP requirements
2) Provide process engineering support for operational and business needs. This includes compressed gas and pharmaceutical unit operations, resolving operational process issues, environmental, safety, technical documentation management and long range investment planning.
3) Provide technical support to Manufacturing, Validation, R&D, Business Development and Quality by performing technical research, engineering development, good engineering practice and cGMP in a broad spectrum of pharmaceutical operations (drug and device) including operational systems, new innovations and business development opportunities
4) Coordinate the modification and troubleshooting of existing equipment as requested by production. This includes scope development, engineering calculations, evaluating risks and alternatives, estimating costs and schedule, arranging for implementation of the work and supervision of the completion of the job.
5) Develop and manage Vendors/Architectural & Engineering Firms/Consultant contract agreements and interactions insuring capital project deliverables meet project design objectives & deliverables in compliance with cGMP requirements
· Strong leadership, organizational planning and project management skills, in addition to technical knowledge, is required to coordinate multi-disciplinary teams
- Thorough knowledge of the pharmaceutical drug commercialization process and team-based matrix management.
- 5+ years related experience in the pharmaceutical industry or a similar organization with process engineering, project management and staff supervisory expertise.
- Thorough knowledge of engineering best practices, Good Manufacturing Practices (GMPs)
- Demonstrated ability to lead and influence others to achieve outcomes.
- Ability to effectively manage internal and external relationships and expectations.
- Ability to effectively guide and lead teams to achieve desired results within timelines and budget commitments.
- Ability to manage multiple tasks concurrently.