Process Engineer III/Senior

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Process Engineer III/Senior
(Weekend day shift, Fri-Sunday)

Onsite, Washington State (relocation provided)

Company Profile
A global CDMO that provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. A nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products.

Process Engineer III/Senior
(Weekend day shift, Fri-Sunday)
Onsite, Washington State (relocation provided)
Company Profile
A global CDMO that provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. A nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products.
What You Will Be Doing

Provide ownership and focus for pharmaceutical processes and technical transfers

Engage in and manage projects and multi-disciplinary teams with direct supervision.

Contribute technical direction for complex projects and exhibit clear communication skills with all levels of employees.

Design, optimize and implement site manufacturing processes to improve efficiency, quality and sustainability

Oversee and assess existing processes and workflows

Establish and track process metrics to monitor process stability and discover areas for improvement

Technical Transfer of new products from both internal and external clients

Ownership of product process from initial quote to product retirement

Perform appropriate development work to define CPPs and CQAs to allow strong execution upon transfer to Manufacturing.

Author validation study documents that demonstrate manufacturing processes are capable of consistently making acceptable product.

Develop and execute validation studies to test and qualify new and improved manufacturing processes.

Troubleshooting, oversight and/or sampling of events within Manufacturing will require occasional off-shift at-location support.

Generate reports summarizing results of studies to document data collected; utilize data obtained to qualify site processes

Review data summaries generated by other departments, assess the data for potential trends or conditions that may adversely impact the quality of the sterile products being manufactured, and ensure that corrective action measures are implemented when required/warranted.

Participate in or perform deviation investigation and evaluation of impact

Implement effective CAPAs

Responsible for optimizing gross profit margin and minimizing deviation rate

Provide necessary reviews for regulatory and client audits and provide responses to audit observations

In-depth understanding of cGMP’s, European regulatory requirements, relevant USP chapters, and scientific principles associated with clean room operations and room classifications as they apply to media fills, sterilization and depyrogenation (dry heat and steam), endotoxin reduction, and microbiological monitoring and control.

Minimal travel (
Process Engineer III:

• Perform job functions with direct supervision. This person must be capable of working independently; however, will not be expected to perform autonomously.
• Authority in pertinent scientific principles and capable of researching applicable guidance, obtaining understanding, and maintaining awareness.
• Subject matter expertise on technical aspects of site processes.
• Perform job functions autonomously with leadership oversight provided to increase effectiveness.
• Knowledgeable in pertinent scientific principles and of applicable existing and new guidance.
• Provide leadership and guidance to others on these topics, as well as update and improve site practices and policies accordingly.
  

What You Will Bring To The Table
Process Engineer III:

• 3-7 years related Pharmaceutical experience or FDA regulated Industry Experience required
• Bachelor’s of Arts or Science with a major in Biology, Chemistry, Physics, or Engineering is required.
• Master’s Degree counts as 2 yrs experience
• Project Management required
• Statistical Analysis
• Lean Manufacturing Principles
• Supervisory or other Leadership Experience required
  

Senior Process Engineer: (in addition to above)

• 5-10 years related Pharmaceutical experience or FDA regulated Industry Experience required; Supervisory or other Leadership Experience required
  

Please reach out to Kiera Kelleher at to find out about this fantastic opportunity!

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Staffing and Recruiting

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