Engineer

Under general supervision, the Operations / Process Engineer supports process optimization, troubleshooting, and engineering initiatives within manufacturing, operations, pilot plant, or capital project environments. This role applies fundamental engineering principles to design and implement system modifications, execute experiments, and improve operational performance. The engineer analyzes and interprets data to support projects of moderate scope and complexity while ensuring compliance with regulatory and quality standards.

Key Responsibilities

• Provide solutions to technical problems of moderate scope and complexity
• Evaluate, select, and apply standard engineering techniques and procedures
• Execute assignments with defined objectives and limited variables
• Initiate and complete routine technical and engineering tasks
• Analyze and present data to support operational improvements and project outcomes
• Serve as a technical expert for troubleshooting equipment and system issues
• Support daily manufacturing operations to meet production schedules and resolve issues
• Audit operational performance and ensure compliance of equipment and systems
• Collaborate with cross-functional teams (Manufacturing, Maintenance, Quality, Validation, Facilities, Utilities, Process Development)
• Develop and implement recommendations for system and process improvements
• Support project managers in executing design, engineering, and construction projects
• Assist in delivering projects within scope, schedule, and budget
• Collaborate with external consultants, architects, and engineering firms
• Review and evaluate vendor quotes for equipment modifications and installations
• Develop basic cost estimates and project schedules
• Own manufacturing equipment within CMMS systems (work orders, PM strategy, spare parts management)
• Enhance system reliability by improving equipment availability and reducing downtime
• Develop and track equipment performance metrics (e.g., uptime, downtime, efficiency)
• Lead equipment improvement and optimization projects
• Act as Subject Matter Expert (SME) for assigned systems (design, maintenance, compliance)
• Support troubleshooting and technical investigations within area of expertise
• Drive maintenance optimization strategies in collaboration with engineering teams
• Support deviation investigations and implement CAPAs related to equipment and systems
• Participate in change control activities and impact assessments
• Ensure compliance with GMP/GLP and internal quality standards
• Promote and support Environmental, Health, and Safety (EHS) initiatives

Core Competencies

• Strong analytical problem-solving and troubleshooting skills
• Applied engineering and technical decision-making
• Basic technical report writing and documentation skills
• Effective verbal communication and cross-functional collaboration
• Validation protocol execution understanding
• Organizational and time management skills
• Adaptability and change management
• Equipment-specific technical expertise
• Computer literacy (e.g., CMMS, MS Office)
• Ability to support technical presentations and reporting

Requirements:
Education & Experience

• Master’s degree in Engineering, OR
• Bachelor’s degree in Engineering + 2 years of relevant experience

Preferred Qualifications

• Working knowledge of pharmaceutical or biotechnology manufacturing processes
• Experience with validation processes (IQ/OQ/PQ)
• Familiarity with regulated environments (GMP/GLP) and technical documentation
• Experience with CMMS systems and equipment lifecycle management
• Knowledge of reliability engineering and maintenance strategies
• Experience with deviation management, CAPA, and change control

Benefits:
• Administrative Shift
• 6-month contract