Process / Operations Engineer

Under general supervision, the Process / Operations Engineer provides technical support for process characterization, optimization, and troubleshooting within manufacturing, operations, pilot plant, and capital project environments. The role applies core engineering principles to design and implement system modifications, conduct experiments, and resolve operational issues. The engineer analyzes data, interprets results, and supports projects of moderate scope and complexity to ensure reliable, compliant, and efficient operations.

FUNCTIONS & RESPONSIBILITIES

• Provide solutions to technical problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques and procedures; seek guidance for atypical or complex issues.
• Perform assignments with clear objectives, requiring investigation of a limited number of variables.
• Initiate and complete routine technical tasks with accuracy and consistency.
• Serve as a technical resource for equipment and systems, supporting troubleshooting and operational reliability.
• Engage directly in daily operations when needed to meet production schedules or resolve complex equipment/process issues.
• Routinely audit operational performance and regulatory compliance for equipment and systems of moderate to significant complexity.
• Collaborate with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation to develop requirements and recommendations for system modifications or improvements.
• Support project managers in executing design, engineering, and construction projects within established timelines and budget constraints.
• Work with consultants, architects, and engineering firms to develop and review standard design documentation.
• Obtain and evaluate vendor quotes for equipment modifications or installations.
• Generate basic project cost estimates and schedules.
• Prepare and maintain technical documentation in accordance with regulatory expectations and Good Documentation Practices (GDP).
• Support change control processes, risk assessments, and impact evaluations.
• Apply engineering science and GMP/GLP principles to production and equipment lifecycle activities.
• Assist with commissioning, decommissioning, and asset lifecycle management tasks.
• Coordinate with cross-functional teams and stakeholders to ensure alignment on technical decisions and project execution.
• Support continuous improvement initiatives focused on equipment reliability, process efficiency, and compliance.
• Manage multiple priorities and meet project deadlines in a dynamic manufacturing environment.

COMPETENCIES & SKILLS

• Working knowledge of pharmaceutical/biotech processes.
• Familiarity with validation processes and regulated documentation requirements.
• Ability to interpret and apply GMP, GLP, and GDP principles.
• Strong analytical and troubleshooting skills for equipment and process issues.
• Ability to operate specialized laboratory or manufacturing equipment as needed.
• Experience with technical documentation and record management in regulated environments.
• Basic technical report writing and presentation skills.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).
• Understanding of validation protocol execution requirements.
• Strong verbal and written communication skills.
• Ability to coordinate cross-functional teams and stakeholders.
• Strong organizational, planning, and project management capabilities.
• Ability to manage multiple priorities and adapt to change.
• Self-motivated, detail-oriented, and proactive approach to work.

EDUCATION REQUIREMENTS

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

PREFERRED QUALIFICATIONS

• Experience supporting equipment and system decommissioning projects in regulated manufacturing environments.
• Strong knowledge of Good Documentation Practices (GDP).
• Experience with change control processes, risk assessments, and impact evaluations.
• Knowledge of commissioning, decommissioning, and asset lifecycle management.
• Ability to manage technical documentation and support regulatory compliance.
• Strong organizational, planning, and project management skills.
• Excellent written and verbal communication skills.
• Technical troubleshooting and problem-solving expertise.
• Experience driving continuous improvement initiatives.
• Ability to collaborate effectively with Engineering, Operations, Maintenance, Quality, and Validation teams.

• 1- year contract with possible extension
• 1st Shift- 6:00 am- 2:30 pm