Position Summary
We are seeking a motivated Process Engineer / Technical Operations Engineer to support manufacturing operations within a sterile production environment. This role will be responsible for investigating deviations, supporting continuous improvement initiatives, authoring GMP documentation, and partnering with cross-functional teams to drive compliance, operational excellence, and process reliability.
The ideal candidate possesses strong technical writing abilities, excellent communication skills, and the ability to manage multiple priorities in a fast-paced manufacturing environment.
Key Responsibilities
- Support deviation investigations, including product impact assessments, root cause analysis, and development of corrective and preventative actions (CAPAs).
- Assist with authoring and managing quality investigations and quality event documentation.
- Create, revise, and maintain GMP documentation including:
- Standard Operating Procedures (SOPs)
- Batch records
- Change controls
- Validation documents
- Technical protocols
- Supporting manufacturing documentation
- Provide technical support for equipment and facility projects within Sterile Supply operations.
- Drive continuous improvement initiatives focused on increasing compliance, improving efficiency, reducing costs, and standardizing processes.
- Analyze operational issues from multiple perspectives including safety, compliance, equipment, automation, process, and personnel to identify and resolve root causes.
- Design, execute, review, and support experimental protocols as required.
- Provide on-the-floor support for manufacturing operations and troubleshooting of process and equipment issues.
- Lead or support projects aimed at:
- Improving Right-First-Time performance
- Reducing deviations
- Implementing CAPAs
- Enhancing operational efficiency
- Increasing regulatory compliance
- Support site safety, environmental, and quality objectives.
- Manage project schedules and ensure key milestones and compliance deadlines are achieved.
- Communicate potential delays and develop mitigation plans when necessary.
- Collaborate closely with Operations, Quality, Planning, Automation, Maintenance, Engineering teams, project stakeholders, and external vendors.
Required Qualifications
Education
- Bachelor's Degree (B.S. or B.A.) in:
- Engineering
- Life Sciences
- Biological Sciences
- Chemistry
- Or a related technical discipline
Experience
- 2-4 years of relevant experience (co-op, internship, and industry experience combined will be considered).
- Strong technical writing and documentation skills.
- Excellent communication, leadership, and teamwork abilities.
- Demonstrated ability to manage projects and meet aggressive deadlines.
- Ability to work effectively in a fast-paced manufacturing environment.
Preferred Qualifications
- Experience with deviation investigations and deviation management systems.
- Root Cause Analysis (RCA) experience.
- Change Control experience.
- Experience supporting biologics, vaccine, pharmaceutical, or sterile manufacturing operations.
- Familiarity with GMP-regulated environments.
- Experience in manufacturing operations or technical support roles.
- SAP experience.
- Power BI experience.
- Experience supporting CAPAs and continuous improvement initiatives.
Key Skills
- Technical Writing
- GMP Documentation
- Root Cause Analysis
- CAPA Management
- Change Control
- Problem Solving
- Cross-Functional Collaboration
- Project Management
- Process Improvement
- Manufacturing Support
- Compliance and Quality Systems
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
