DME is looking for a process engineer with aseptic fill/finish experience in the regulated life sciences industry. This is a full time senior level position in our growing Pennsylvania office, reporting to the vice president of engineering. This position will provide opportunities to work on a variety of challenging and rewarding projects with diverse technologies and job responsibilities. Working in a small team environment, the successful candidate will enjoy lead project roles with opportunities to exercise and further develop well-rounded skills in facility front-end engineering, process equipment design, and engineering project management. This person will interact directly with clients and collaborate with other architectural and engineering disciplines to ensure that user requirements are met on technically complex projects. Prior experience with cGMP formulation and filling operations is required, with preference given to candidates with design experience in process utilities, drug product formulation, sterile manufacturing for vaccines and other parenteral products, RABs and barrier isolation, lyophilization and packaging unit operations.
DME is committed to delivering design solutions for advanced technology facilities that we can be proud of. We are driven by the strong desire to get results for our clients and share in their success. Our focus is on developing a company culture that aspires to the core values of integrity, dependability, teamwork, humility, versatility and passion.
Since 2001, DME has built a solid reputation for strong technical expertise, responsive service, and getting the job done right. Working in a dynamic small team environment, we have cultivated a collaborative, no-pretense workplace where everyone’s contribution is valued. We see a diverse array of interesting and challenging projects – providing an exceptional opportunity to develop career-enhancing technical and professional skills through exposure to a rich variety of technologies and project responsibilities. Learn more about team DME at www.DMEforLife.com.
- Work directly with clients to develop process definition and identify process user requirements applicable to each project.
- Collaborate with facility planners to program manufacturing space, layout process equipment, and develop facility flows and adjacencies.
- Develop process narratives, throughput analysis, process flow diagrams, P&IDs, process equipment lists and specifications.
- Support the development of design deliverables for process equipment, process piping, process instrumentation, central and clean utilities and process automation.
- Support construction administration, startup, commissioning and qualification phases.
- Provide engineering and consulting services to support the design, operation, troubleshooting and improvement of process systems and clean utilities.
- Assist with development of client relationships and new project proposals.
- Scheduling, budgeting and management of project work.
Qualifications and Requirements
- Engineering degree, mechanical, chemical or bioengineering preferred.
- 7+ years’ experience with process equipment and utilities in formulation and fill/finish manufacturing facilities.
- Ability to function as the process lead and manage projects as needed.
- Knowledge and understanding of cGMP regulatory requirements for drug product facilities and manufacturing operations.
- Experience with lyophilization, filling machines, check weighing, vial/stopper washers, packaging and labeling operations is desirable.
- Ability to prepare/control project documentation; schedule/track project progress; work within defined project scope & budget.
- Works collaboratively in a cross-functional team environment and wins support from coworkers; Ability to plan and supervise the development of technical deliverables.
To apply: Email resume to firstname.lastname@example.org