Summary
We are seeking an Engineer to provide technical support to manufacturing operations in a regulated pharmaceutical/biotechnology environment. This position is responsible for ensuring the continuous operation of manufacturing processes by performing troubleshooting, supporting process optimization initiatives, coordinating technical response during operational events, and maintaining compliance with current Good Manufacturing Practices (GMP) and applicable regulatory requirements.
The Engineer will work in a highly collaborative environment alongside Manufacturing, Maintenance, Automation, Utilities, Facilities, Quality Assurance, Validation, and Process Development teams to support safe, compliant, and efficient manufacturing operations.
Responsibilities
- Provide day-to-day technical engineering support to manufacturing operations.
- Perform equipment and process troubleshooting to minimize downtime and maintain production continuity.
- Lead technical response efforts during operational events and coordinate escalation activities when required.
- Evaluate manufacturing issues, identify root causes, and implement effective technical solutions.
- Monitor manufacturing performance and recommend process improvements.
- Support equipment upgrades, replacements, process modifications, and engineering projects.
- Apply engineering principles to process optimization, experiments, and capital improvement initiatives.
- Support manufacturing quality systems, including deviations, equipment qualification, process validation, SOP development, training, and new product introductions.
- Prepare clear, accurate, and compliant technical documentation, including shift reports and operational summaries.
- Collaborate with cross-functional teams to ensure operational excellence and regulatory compliance.
- Function as the primary technical engineering support during assigned manufacturing shifts.
Qualifications
- Master's Degree in Engineering OR Bachelor's Degree in Mechanical, Electrical, Industrial, Chemical Engineering, or a related Engineering discipline with a minimum of 2 years of engineering experience.
- Experience troubleshooting manufacturing equipment and/or production processes in a regulated environment.
- Knowledge of pharmaceutical or biotechnology manufacturing operations.
- Working knowledge of GMP regulations.
- Strong analytical and problem-solving skills.
- Technical writing and documentation experience.
- Effective written and verbal communication skills in both English and Spanish.
- Ability to present technical information clearly and professionally.
- Strong teamwork and collaboration skills.
- Ability to prioritize multiple assignments and work independently.
- The ideal candidate demonstrates:
- Strong troubleshooting and analytical thinking skills.
- Sound technical judgment and decision-making abilities.
- Leadership during operational events.
- Excellent communication and documentation skills.
- Ability to work effectively in a fast-paced manufacturing environment.
- Strong collaboration and teamwork.
- Commitment to safety, quality, and compliance.
Work Schedule
- The selected candidate will complete approximately two months of training on a regular 8:00 a.m. – 5:00 p.m. schedule.
- After the training period, the role transitions to a 12-hour rotating day shift (5:00 a.m. – 5:30 p.m.).
- Once fully trained and operating independently, the employee will rotate to the night shift (5:00 p.m. – 5:30 a.m.).
- This position supports a 24/7 manufacturing operation, including nights, weekends, holidays, and extended hours as business needs require.
- Candidates must be willing and able to work rotating shifts.
Job Type: Full-time
Pay: $30.00 - $35.00 per hour
Experience:
- GMP regulations: 2 years (Preferred)
- • Technical writing and documentation : 2 years (Preferred)
- pharmaceutical or biotechnology manufacturing operations: 2 years (Preferred)
- troubleshooting manufacturing equipment : 2 years (Preferred)
- production processes in a regulated environment: 2 years (Preferred)
Work Location: In person
