Process Engineer III

Job Description:

Position Overview:

We are seeking a highly skilled Process Engineer III to support our biotech manufacturing operations. The successful candidate will play a key role in troubleshooting, optimizing processes, and supporting capital projects. This role requires expertise in manufacturing equipment, process improvements, and documentation management.

Contract Duration: 8 Months (April 2025 - December 2025)

Pay rate: $27.51- $45.86/PH depending on experience.

Key Responsibilities:

Manufacturing Support:

• Develop deep technical expertise on manufacturing equipment and processes.
• Troubleshoot major equipment breakdowns and resolve quality issues in production suites.
• Provide SME (Subject Matter Expert) support to Manufacturing and cross-functional teams regarding process equipment design and operations.
• Perform technical analyses, including:PI data review. CIP/SIP circuit assessments. Management of Change (MOC) evaluations. Flow path analyses.
  
  

Project Execution:

• Lead and support plant projects involving equipment modifications and process improvements.
• Execute commissioning protocols (installation, operation, CIP/SIP, wet testing) with guidance from the supervisor.
• Ensure adherence to project timelines, scope, and budgets.
  
  

Documentation and Compliance:

• Review and revise SOPs, work instructions, and maintenance procedures based on CAPA, equipment/process changes, and error prevention activities.
• Complete engineering review and approval of batch records.
• Initiate and manage Engineering Document Change Requests (EDCRs), including updates to engineering drawings.
• Author commissioning protocols and ensure compliance with site standards.
  
  

Project Involvement:

Process and Equipment Design Changes:

• Support investigations and implement design changes for new customer first-run scale activities.
• Drive or influence change controls through WorkFront.
• CAPEX Project Support: Buffer Valve Array Drain Hard Pipe:Submit lump sum funding requests. Coordinate installation with external piping contractors.
  
  

IBF to SMCC Hardpipe:Refine mechanical and automation scope.

Submit funding requests and draft change requests.

Coordinate with mechanical and automation contractors.

Manage scope, schedule, and budget.

SMCC Filter Housing Upgrade:Refine mechanical scope and submit funding requests.

Draft and own change requests.

Oversee mechanical and automation changes with contractors.

Ensure project alignment with budget and timeline.

EM Conflict Resolution:Define and resolve EM conflicts involving WFI, caustic, and salt systems.

Propose and implement mechanical modifications (valving).

Coordinate automation changes with site and external automation teams.

Maintain project scope, schedule, and budget.

VRF Skid Commissioning:Oversee installation with piping contractors.

Support commissioning and cleaning of the new skid.

Required Skills and Qualifications:

• Strong experience in biotech manufacturing or fluid processing environments.
• Hands-on expertise with CIP/SIP systems, PI data analysis, and flow path reviews.
• Proficiency in managing CAPEX projects, including scope, schedule, and budget oversight.
• Familiarity with automation systems and collaborating with external contractors.
• Skilled in creating and reviewing SOPs, commissioning protocols, and engineering documentation.
• Strong problem-solving skills with the ability to manage multiple priorities simultaneously.
  
  

Preferred Qualifications:

• Experience with WorkFront or similar project management tools.
• Knowledge of change control processes and deviation management.
• Excellent communication and collaboration skills, with the ability to work cross-functionally.-
  
  

$ 27.51/hr

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