Job Details

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:

1. Provide ownership and focus for pharmaceutical processes and technical transfers.
2. Engage in and manage projects and multi-disciplinary teams with direct supervision.
3. Contribute technical direction for complex projects and exhibit clear communication skills with all levels of employees.
4. Design, optimize and implement site manufacturing processes to improve efficiency, quality and sustainability.
5. Oversee and assess existing processes and workflows.
6. Establish and track process metrics to monitor process stability and discover areas for improvement.
7. Technical Transfer of new products from both internal and external clients.
8. Ownership of product process from initial quote to product retirement.
9. Perform appropriate development work to define CPPs and CQAs to allow strong execution upon transfer to Manufacturing.
10. Author validation study documents that demonstrate manufacturing processes are capable of consistently making acceptable product.
11. Develop and execute validation studies to test and qualify new and improved manufacturing processes.
12. Troubleshooting, oversight and/or sampling of events within Manufacturing will require occasional off-shift at-location support.
13. Generate reports summarizing results of studies to document data collected; utilize data obtained to qualify site processes.
14. 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.
15. Participate in or perform deviation investigation and evaluation of impact.
16. Implement effective CAPAs.
17. Responsible for optimizing gross profit margin and minimizing deviation rate.
18. Provide necessary reviews for regulatory and client audits and provide responses to audit observations.
19. 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 required.

Process Engineer I:

• Expected to perform job functions with direct supervision. This person must be capable of working independently; however, will not be expected to perform autonomously.
• Expected to be knowledgeable in pertinent scientific principles and capable of researching applicable guidance, obtaining understanding, and maintaining awareness.
• Expected to obtain subject matter expertise on technical aspects of site processes.

Process Engineer II: (in addition to above)

• Expected to perform job functions autonomously with leadership oversight provided to increase effectiveness.
• Expected to be knowledgeable in pertinent scientific principles and of applicable existing and new guidance.
• Expected to obtain and maintain subject matter expertise on technical aspects of site processes.

Process Engineer III: (in addition to above)

• Expected to perform job functions autonomously and effectively.
• Expected to be an authority in pertinent scientific principles and applicable existing and new guidance.
• Expected to be an authority on technical aspects of site processes.
• Expected to provide leadership and guidance to others on these topics, as well as update and improve site practices and policies accordingly.

Senior Process Engineer: (in addition to above)

• Expected to 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:

• A Bachelor's of Arts or Science with a major in Biology, Chemistry, Physics, or Engineering is required.
• 0 to 5 year(s) related Pharmaceutical experience or FDA regulated Industry Experience is desired.
• Master's Degree counts as 2 yrs experience.
• Project Management.
• Statistical Analysis.
• Lean Manufacturing Principles.

Process Engineer II: (in addition to above)

• 2 to 5 year(s) related Pharmaceutical experience or FDA regulated Industry Experience required.
• Supervisory or other Leadership Experience required.

Process Engineer III: (in addition to above)

• 3-7 years related Pharmaceutical experience or FDA regulated Industry Experience required.
• Supervisory or other Leadership Experience required.
• Project Management 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.
• Project Management required.

Please reach out to Joe Schneck at ...@scientificsearch.com to find out about this fantastic opportunity!

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Management, Manufacturing, and Engineering

Industries

• Pharmaceutical Manufacturing