The Senior Design & Process Engineer will independently lead the characterization, optimization, and troubleshooting of complex systems and processes within operations, manufacturing, pilot plant, and capital project environments. This role applies advanced engineering principles to the design and implementation of major system modifications and experiments, driving innovation and operational excellence in a regulated pharmaceutical or biotechnology setting.

Key Responsibilities

• Lead complex or novel engineering assignments requiring innovative techniques and solutions.
• Develop and implement engineering policies and procedures across multiple organizational units.
• Supervise and mentor engineers, associates, and technicians on both ongoing and project-specific tasks.
• Apply advanced engineering techniques across disciplines and serve as a recognized technical expert in at least one specialty area.
• Plan and conduct projects using mature engineering knowledge and cross-functional collaboration.
• Design Engineering
• Develop creative technical solutions to complex problems involving system and facility modifications.
• Collaborate with research, manufacturing, process development, QA, validation, utilities, and facilities teams to define project requirements.
• Manage engineering deliverables within schedule, budget, and quality constraints.
• Coordinate external consultants, architects, and engineering firms to standardize design documentation.
• Prepare and manage departmental and project budgets across multiple disciplines.

Core Competencies

• Strong working knowledge of pharmaceutical/biotech processes and validation protocols.
• Proficiency in GLP/GMP documentation and compliance.
• Ability to operate specialized lab equipment and software tools.
• Demonstrated skills in:
• Technical report writing and presentations
• Analytical problem solving and applied engineering
• Project scheduling, budgeting, and completion tracking
• Vendor and contractor management
• Negotiation, conflict resolution, and team leadership
• Expertise in at least three engineering technology domains.
• Financial analysis and cost development capabilities.

Requirements

Education & Experience Requirements

• Doctorate OR
• Masters + 2 years of Engineering experience OR
• Bachelor's in Engineering + 4 years of Engineering experience.
• Degree in: Mechanical Engineering or Chemical Engineering with project management experience.

Preferred Qualifications

• Experience in pharmaceutical or biotech equipment commissioning, installation qualification (IQ), and validation.
• Expertise in Clean-in-Place (CIP) and Steam-in-Place (SIP) cycle development.
• Skilled in developing project plans, strategies, and execution timelines.
• Familiarity with Maximo or similar asset management systems.
• Ability to thrive in a fast-paced, multitasking environment.

Benefits

• 6-months contract with possible extension.