Job Description

The Sr. Engineer independently leads and executes complex engineering activities related to process optimization, troubleshooting, system/facility modifications, and capital projects within manufacturing, operations, pilot plant, or engineering environments. This role applies advanced engineering principles, develops technical solutions, directs project execution, and provides expert guidance on methodologies, validation, and documentation in a highly regulated pharmaceutical/biotech setting.

Key Responsibilities

• Lead complex or novel engineering assignments requiring development of new or improved techniques and procedures.
• Develop engineering policies and procedures impacting multiple organizational units.
• Supervise, coordinate, and review work from engineers, associates, and technicians on both ongoing and project‑based tasks.
• Apply advanced engineering techniques and adapt specialized methods to diverse assignments.
• Utilize engineering knowledge beyond core discipline to support cross‑functional initiatives.
• Serve as a peer‑recognized subject matter expert (SME) in at least one engineering technology area.
• Plan and conduct engineering projects using mature technical judgment and scientific methodology.
• Develop technical solutions to complex problems requiring creativity, innovation, and engineering expertise.
• Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation to define requirements for major system or facility modifications.
• Partner with Project Managers to deliver engineering projects within schedule, budget, and quality expectations.
• Coordinate external consultants, architects, and engineering firms in developing standard design documentation.
• Develop departmental or multi‑disciplinary project budgets and manage cost controls for assigned areas.

Skills

• Working knowledge of pharmaceutical/biotech manufacturing processes.
• Familiarity with validation processes, protocol execution, and documentation in regulated environments.
• Ability to interpret and apply GLP, GMP, GDP and engineering science to production systems.
• Ability to operate specialized laboratory and engineering equipment.
• Technical report writing and verbal communication skills.
• Comprehensive understanding of validation requirements for new equipment installations.
• Ability to manage multiple projects simultaneously and determine when additional internal/external resources are required.
• Ability to manage contractors, vendors, and cross‑functional teams.
• Working knowledge of financial analysis tools and project cost development.
• Ability to develop schedules, manage change, and ensure completion and follow‑up of engineering tasks.

Requirements

Required Education

• Doctorate in Engineering, OR
• Master’s degree + 2 years of engineering experience, OR
• Bachelor’s degree in Engineering + 4 years of engineering experience

Preferred Qualifications

• Experience with packaging equipment.
• Experience in design of new equipment or processes.
• Engineering project experience (capital projects, system modifications, facility upgrades).
• Strong knowledge of validation (equipment, process, CSV).
• Experience in medical device or pharmaceutical manufacturing environments.
• Bilingual (English/Spanish)

Benefits

• 8-month contract with possible extension
• Administrative Shift