3 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. 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 Kiera@scientificsearch.com 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 Referrals increase your chances of interviewing at Scientific Search by 2x Get notified about new Senior Process Engineer jobs in Washington, United States . Senior Process Innovation Engineer, Amazon Logistics Bellevue, WA $107,600.00-$177,900.00 2 weeks ago Senior Industrial Process Engineer - Water/Wastewater Spokane, WA $131,000.00-$164,000.00 2 weeks ago Sr. Manufacturing Engineer, Process Development, Kuiper - Solar Sr. Manufacturing Engineer, Process Development, Kuiper - Solar Senior Operations Engineer, Amazon Logistics Bellevue, WA $107,600.00-$177,900.00 1 week ago Senior Manufacturing Engineer (Need Visa independant) Senior Manager, Process (Individual Contributor) Olympia, WA $75,400.00-$182,549.00 3 days ago Senior Operations Engineer, NA Capacity Engineering Sr Program Manager, Benchmarking, Process Improvement, Transportation Engineering Services (TES) Bellevue, WA $104,100.00-$185,000.00 3 weeks ago Bellevue, WA $155,700.00-$269,100.00 4 days ago Sr. Manufacturing Engineering Manager - Aerospace Principal Solutions Architect- Conga CPQ and CLM Liberty Lake, WA $96,000.00-$175,000.00 1 week ago Process Engineer - Analytical and Process Testing Spokane, WA $77,968.80-$115,800.00 1 week ago Sr. Process Engineer – Cell Therapy (Hybrid- Seattle, WA) Seattle, WA $77,968.80-$110,000.00 3 days ago Process Engineer II - Site, based, Redmond, WA Process Engineer – Industrial Water/Wastewater Seattle, WA $95,000.00-$120,000.00 3 months ago Sr. Process Development Engineer - Harnessing, Kuiper Redmond, WA $128,600.00-$213,600.00 2 weeks ago Sr. Process Development Engineer - Harnessing, Kuiper Process Safety Engineer, Global Process Safety Management, Workplace Health & Safety Advanced Technology - Semiconductor Process Engineer We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr