Senior Process Engineer

Hi,

My name is Karthik Mutyala, and I am a Recruitment Manager with Stark Pharma Solutions, specializing in opportunities across the Pharmaceutical, Biotechnology, Medical Device, and Life Sciences industries.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

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https://www.linkedin.com/company/99455976/

Role: Senior Process Engineer

Location: Bend, OR

Duration: 12+ Month Contract

Position Overview

We are seeking an experienced Senior Process Engineer to support pharmaceutical and API manufacturing projects from design through commissioning and qualification. This role will provide technical leadership for process engineering activities, equipment design reviews, vendor management, and facility implementation within a GMP-regulated environment.

The ideal candidate will have extensive experience in pharmaceutical process design, OSD manufacturing, cleanroom facilities, and project execution across the full project lifecycle.

Key Responsibilities

• Lead process engineering activities for pharmaceutical and API manufacturing projects.
• Review, redline, and approve engineering design packages, including:
• P&IDs
• Equipment Specifications
• Data Sheets
• Equipment Calculations
• Technical Drawings
• Provide oversight and technical direction to OEM equipment vendors throughout project execution.
• Ensure facility and process designs comply with GMP requirements and cleanroom design standards.
• Support process equipment selection, installation, startup, commissioning, qualification, and validation activities.
• Participate in HAZOPs, risk assessments, and process safety reviews.
• Collaborate with Engineering, Manufacturing, Quality, Validation, and external vendors to ensure successful project delivery.
• Verify compliance with Occupational Exposure Limits (OEL) and Occupational Exposure Bands (OEB) throughout facility and process design.
• Support troubleshooting, optimization, and continuous improvement initiatives for manufacturing processes.
• Contribute to project planning, execution, and technical decision-making across multiple workstreams.

Required Qualifications

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or a related technical discipline.
• 10+ years of process engineering experience within pharmaceutical, API, biotechnology, or life sciences manufacturing environments.
• Strong experience reviewing and approving process engineering design documentation.
• Hands-on experience with:
• Oral Solid Dosage (OSD) Manufacturing
• Powder Handling Systems
• CIP (Clean-in-Place) Systems
• SIP (Sterilize-in-Place) Systems
• Thorough understanding of GMP facility design and ISO cleanroom requirements.
• Experience managing OEM equipment suppliers and external engineering partners.
• Experience leading projects through design, construction, commissioning, qualification, and validation phases.
• Strong knowledge of process safety, risk assessments, and HAZOP methodologies.