Process Engineer – API Manufacturing

United Pharma Technologies Inc; Sacramento (CA); On-site; USD 55,000 - 62,000; Full time

Benefits offered by this job

Health Insurance

401(k) retirement plan

Paid Time Off

Job summary

United Pharma Technologies is seeking experienced Process Engineers with a strong API manufacturing background to provide hands-on engineering support in a GMP environment. The ideal candidate will troubleshoot processes, optimize operations, and contribute to safe, compliant production.

The role covers process scale-up, equipment startup, and technical investigations while collaborating with Manufacturing, Quality, and Engineering to improve efficiency and manufacturing performance.

Qualifications

• 5+ years of experience in Process Engineering, preferably in API/pharma manufacturing.
• Hands-on GMP manufacturing process troubleshooting and optimization.
• Experience with equipment startup, manufacturing support, and process improvements.
• Proficiency in technical documentation—batch records and GMP procedures.
• Strong understanding of process safety in regulated environments.
• Ability to work independently with cross-functional teams.

Responsibilities

• Provide technical engineering support for API manufacturing, including process scale‑up and startup.
• Develop and revise manufacturing documentation and GMP records.
• Lead process improvements to reduce downtime and improve cycle times.
• Support equipment setup, facility readiness, and product changeovers.
• Troubleshoot equipment and process issues to ensure reliable production.
• Lead investigations and CAPA activities to identify root causes.
• Collaborate with Manufacturing, Quality, and Engineering to resolve challenges.
• Support operator training and adherence to procedures and safety standards.

Skills

Process engineering

GMP manufacturing

Troubleshooting

Documentation

Cross-functional collaboration

Safety compliance

Tools

P&ID interpretation

Process safety analysis

Job description

Role: Process Engineer – API Manufacturing

Company: United Pharma Technologies

Duration: 12 Months (Potential Conversion to Permanent)

Industry: Pharmaceutical Manufacturing

Job Overview

We are seeking experienced Process Engineers with a strong background in Active Pharmaceutical Ingredient (API) manufacturing to provide hands‑on engineering support for manufacturing operations within a regulated GMP environment.

The ideal candidate will have a strong chemical engineering background and practical experience in API manufacturing, process optimization, equipment troubleshooting, and process improvement. This role involves supporting day‑to‑day production activities, process scale‑up, equipment startup, and technical investigations while ensuring compliance with GMP, safety, and quality requirements.

The candidate should be capable of independently managing engineering activities and collaborating with Manufacturing, Quality, and Engineering teams to improve operational efficiency and manufacturing performance.

Key Responsibilities

• Provide technical engineering support for API manufacturing operations, including process scale‑up, equipment startup, troubleshooting, and process optimization.
• Develop, review, and revise manufacturing documentation, including batch records, work instructions, cleaning procedures, and GMP documentation.
• Lead process improvement initiatives to reduce equipment downtime, improve cycle times, and enhance manufacturing safety, quality, and productivity.
• Support equipment setup, qualification, facility readiness, product changeovers, and manufacturing process improvements.
• Troubleshoot manufacturing equipment and process‑related issues to ensure reliable and efficient production.
• Lead technical investigations and support CAPA activities to identify root causes and implement corrective actions.
• Collaborate with Manufacturing, Quality, and Engineering teams to resolve production challenges and maintain compliant operations.
• Support operator training and ensure adherence to established manufacturing procedures and safety standards.

Required Qualifications

• 5+ years of experience in Process Engineering, preferably within API or pharmaceutical manufacturing.
• Strong hands‑on experience in GMP manufacturing process troubleshooting and process optimization.
• Experience with equipment startup, manufacturing support, and process improvement activities.
• Proficiency in technical documentation, including batch records, work instructions, and GMP procedures.
• Strong understanding of process safety and regulated manufacturing environments.
• Ability to independently manage engineering activities and work effectively with cross‑functional teams.

Equipment Experience

• Hands‑on experience with API manufacturing equipment such as:
• Reactors
• Dryers
• Mills

Preferred Qualifications

• Experience with PHA (Process Hazard Analysis) and PSSR (Pre‑Startup Safety Review).
• CAPA and root cause investigation experience.
• Equipment qualification and validation support.
• Ability to interpret P&IDs (Piping and Instrumentation Diagrams).
• Experience with mass balance and emission calculations.
• Familiarity with process safety assessments and manufacturing risk mitigation.

Pay Scale

• Anticipated hourly pay range: $40/hr to $45/hr

Employees hired into this position are eligible for the following benefits, subject to applicable plan terms and eligibility requirements:

Health Insurance

Medical, dental, and vision insurance options are available through a third‑party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits

A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO)

No PTO is provided other than that required by applicable state and local law