Process Engineer

Validation & Engineering Group Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas: Laboratory Compliance Computer Engineering Project Management Validation and other services.

We are seeking an experienced Process Engineer to provide technical engineering support within a regulated pharmaceutical/biotechnology manufacturing environment. The Process Engineer will work closely with Engineering Manufacturing Quality Validation Maintenance and other cross-functional teams to support process performance equipment and system improvements troubleshooting capital projects and continuous improvement initiatives. The ideal candidate is a hands-on engineer with strong technical problem-solving skills experience working in GMP-regulated manufacturing environments and the ability to independently manage engineering activities from problem identification through implementation and closure.

Description:

• Provide day-to-day process engineering support to manufacturing and engineering operations.
• Evaluate process performance and identify opportunities to improve reliability efficiency capacity quality and operational performance.
• Lead or support troubleshooting and root-cause investigations related to manufacturing processes equipment and systems.
• Develop and implement engineering solutions to address process and equipment issues.
• Support capital projects equipment upgrades system modifications and process improvement initiatives.
• Develop and review technical documentation including engineering assessments specifications protocols reports procedures and change-control documentation.
• Support equipment and process design reviews technical evaluations and implementation activities.
• Coordinate engineering activities with Manufacturing Quality Validation Automation Maintenance and other technical groups.
• Support commissioning qualification validation startup and turnover activities as required.
• Participate in change controls deviations investigations CAPAs and risk assessments from an engineering perspective.
• Analyze process and equipment data to identify trends recurring issues and improvement opportunities.
• Provide technical recommendations and support the development of corrective and preventive solutions.
• Coordinate activities with vendors contractors and equipment suppliers when required.
• Ensure engineering activities are performed in accordance with applicable GMP requirements engineering standards procedures and safety expectations.
• Maintain clear documentation and communicate project status technical issues risks and recommendations to stakeholders.
• Support continuous improvement and standardization initiatives within the Engineering organization.

Qualifications:

• Bachelors degree in Chemical Engineering Mechanical Engineering Industrial Engineering Bioengineering or a related engineering discipline.
• Relevant process engineering experience within the pharmaceutical biotechnology medical device or regulated manufacturing industry.
• Strong understanding of manufacturing processes equipment utilities and engineering principles.
• Experience troubleshooting process and equipment-related issues in a manufacturing environment.
• Knowledge of GMP requirements change control deviations CAPA and engineering documentation practices.
• Experience supporting equipment modifications process improvements or capital projects.
• Ability to analyze technical data and translate findings into practical engineering solutions.
• Strong technical writing documentation and communication skills.
• Demonstrated ability to work independently while collaborating effectively with multidisciplinary teams.
• Strong organizational skills with the ability to manage multiple activities and priorities.
• 5 years of relevant process or manufacturing engineering experience within the pharmaceutical or biotechnology industry.
• Experience supporting biopharmaceutical manufacturing processes and equipment.
• Experience with commissioning qualification validation and equipment startup.
• Familiarity with process optimization process characterization troubleshooting methodologies and root-cause analysis.
• Experience supporting capital projects and equipment/system lifecycle activities.
• Working knowledge of automation and process control systems.
• Experience working in a highly regulated GMP manufacturing environment.

Key Competencies: Process Engineering Manufacturing Support Troubleshooting Root Cause Analysis Process Optimization Equipment & Systems Technical Documentation Change Control CAPA GMP Compliance Capital Projects CQV Support Cross-Functional Collaboration Continuous Improvement

At Validation & Engineering Group people always come first. We believe that when youre empowered to do your best work bold ideas thrive and real progress happens. This isnt just a job - its an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven supportive team.

Excited to build something meaningful together We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race color religion sex sexual orientation gender identity national origin veteran status or disability status.

Required Experience:

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