Senior Process/Project Engineer

Dps Group Global - Rahway, NJ

Full-time - Mid Level

Rahway, NJ

About the position

The BioPharma Senior Process Project Engineer at DPS Group is responsible for overseeing equipment commissioning and calibration activities within a GMP environment. This role requires a blend of technical expertise and project management skills to ensure project accuracy and quality from conception to completion, while collaborating with cross-functional teams to meet evolving manufacturing and laboratory needs.

Responsibilities

• Familiarity with critical utilities, TFF, stainless steel/Hastelloy portable reactors, chromatography skids, containment expertise, HTHM/solvent dispensing, temperature control modules, milling equipment, and single-use equipment.
• Work with a cross-functional team to respond to GMP manufacturing and laboratory utilization needs for CDMO client projects.
• Engage in new product introduction activities including facility fit analysis, process flow diagram, and P&ID development.
• Support facility design and capital project execution with expert process and technical input.
• Provide technical guidance for small project execution with minimal supervision.
• Assemble and lead small project teams for capital project planning and execution.
• Assist Facilities group in identifying, developing, planning, and delivering expense projects and managing facilities shutdown activities.
• Proactively recommend improvements in site processes and procedures.
• Qualify vendors, solicit bids, review bid contents, expedite equipment delivery, and coordinate vendor equipment startup.
• Develop project management and quality project delivery procedures, adhering to relevant policies for interaction with project design and delivery partners.
• Maintain familiarity with technology advancements in cell and gene therapy production processes, equipment, instrumentation, and systems.
• Understand end-to-end business processes, ensuring compliance with internal and external regulators, and perform process re-engineering.
• Analyze and manipulate data to identify trends and share process road mapping with stakeholders.
• Direct and manage engineers on new product introductions and technical transfers, including new technologies.
• Evaluate raw materials, develop process fits, conduct safety and environmental reviews, and ensure regulatory and validation compliance.

Requirements

• B.S. in an Engineering discipline.
• Familiarity with project identification and development, and expedited project delivery approaches.
• Ability to combine technical knowledge with project delivery for optimal outcomes while managing cost and schedule constraints.
• Strong organizational, interpersonal, speaking, and written communication skills.
• Ability to prioritize multiple commitments and solve technical problems effectively.
• Flexibility to shift priorities according to changes in department or facility needs.

Nice-to-haves

• Continuous learning mindset and pursuit of training and development opportunities.
• Support for a culture of excellence and teamwork.
• Customer service orientation and ability to manage difficult situations.
• Strong planning and organizing skills.

Benefits

• Health insurance
• 401k retirement plan
• Paid holidays
• Professional development opportunities