Management Recruiters of Edison · 2 days ago
Sr. Process Engineers – Pharma Technical Services - 5 openings
Spokane, WA
Full-time
Onsite
Mid, Senior Level
$120K/yr - $157K/yr
5+ years expManagement Recruiters of Edison is representing a global and growing BioPharma CDMO company seeking 5 Sr. Process Engineers in their Pharma Technical Services group. This role involves managing large scale projects, providing technical direction, and refining department processes while leading multi-disciplinary teams.
Staffing & Recruiting
Responsibilities
Design, optimize, implement 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
Evaluate incoming processes for robustness, efficiency and fit
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
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
Qualification
Required
Bachelors of Science in Arts or Science or related technical degree
5+ years of technical services experience in the BioPharma industry
Technical service experience supporting the existing commercially manufactured products or Tech Transfer of New Products from Development to Manufacturing
Ability to work independently in a fast-paced CDMO environment
Preferred
BS in Biology, Chemistry, Physics, or Engineering
Experience with Pharma sterile aseptic manufacturing, filling, Lyophilization
Advanced degree (MS Degree counted as 2 years of experience)
Some Leadership, Supervisory experience over Jr. Engineers, Technicians
Some Technical Transfer Project Management experience
Experience with Statistical Analysis, Lean Manufacturing Principles
Experience handling Change Control and CAPA situations
Ability to grow into a Subject Matter Expert (SME) for Manufacturing & Process unit Operations
Benefits
Medical
Vision
Dental
15 days ’ vacation/Sick time
10 - Holidays
401k (match up to 4%)
Company
Management Recruiters of Edison
Welcome To Management Recruiters of Edison.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase