Engineer

Under general supervision, the Process Engineer supports characterization efforts, process optimization strategies, and troubleshooting of operational issues within manufacturing, operations, pilot plant, and capital project environments. This role applies fundamental engineering principles to design and implement system modifications, execute experiments, and support small to moderate-scope engineering projects. The engineer organizes, analyzes, and presents technical data to support operational performance and project decisions.

KEY RESPONSIBILITIES

• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques and procedures under general supervision.
• Perform assignments with clear objectives, requiring investigation of a limited number of variables.
• Initiate and complete routine technical tasks supporting daily operations and project deliverables.
• Serve as a technical resource for equipment and systems troubleshooting; support daily operations as needed to maintain schedules and resolve issues.
• Routinely audit operational performance and regulatory compliance of multiple equipment items or systems of moderate complexity.
• Collaborate with cross-functional departments (Manufacturing, Maintenance, QA, Utilities, Facilities, Validation, R&D) to define requirements and recommendations for system improvements or modifications.
• Support project managers in completing design, engineering, and construction activities within budget and schedule.
• Work with consultants, architects, and engineering firms to develop standard design documents.
• Obtain, review, and critique quotes for equipment modifications or new installations.
• Prepare basic project cost estimates and schedules.
• Support preparation and execution of validation protocols.
• Prepare basic technical reports, documentation, and presentations to summarize findings.
• Ensure compliance with GLP, GMP, safety standards, and internal procedures.
• Apply engineering science and regulatory knowledge to support production and operational activities.

REQUIRED SKILLS & COMPETENCIES

• Problem-solving and applied engineering skills.
• Familiarity with validation processes and documentation in a regulated environment.
• Ability to interpret and apply GLPs, GMPs, and regulatory expectations.
• Proficiency with specialized laboratory equipment and engineering software.
• Strong verbal communication and basic technical writing skills.
• Ability to organize work, manage multiple tasks, and adapt to changing priorities.
• Competency in analytical problem solving and basic technical presentations.
• Computer literacy (Word, Excel, PowerPoint, and general engineering tools).

Requirements

EDUCATION & EXPERIENCE

• Master’s degree, OR
• Bachelor’s degree in Engineering + 2 years of Engineering experience
• Background in Chemical Engineering, Industrial Engineering, Biotechnology, or related technical disciplines.

PREFERRED QUALIFICATIONS (Stand-Out Attributes)

• Engineering experience in manufacturing operations within biotech, pharmaceutical, or regulated environments.
• Hands-on experience with process engineering, automation systems, process equipment, or production systems.
• Familiarity with Lean Six Sigma, Kaizen, root cause analysis, or other continuous improvement methodologies.
• Demonstrated ability to troubleshoot equipment/process issues and support CAPA activities.
• Strong understanding of cGMP, compliance, and regulatory documentation requirements.
• Proven cross-functional collaboration with operations, quality, and maintenance teams.
• Strong communication skills, adaptability, and customer-focused mindset.

Benefits

• 6-month contract
• Administrative Shift