Sr. Process Engineers – Pharmaceutical Technical Services

Our client – a global and growing BioPharma CDMO company needs multiple Process Engineers in the Pharma Technical Services group, located at their expanding plant in WA state. Excellent total comp. up to $143K+ with excellent Benefits + Relocation Bonus. Client will sponsor for H1B Visa transfer. This is a permanent Direct Hire and not a contractor role

Job Posting # 2728

Job Title: Sr. Process Engineers – Pharmaceutical Technical Services

Location: Spokane, WA

Relocation: YES – The client offers a generous lumpsum bonus for relo assistance.

Compensation: Salary range $110K - $130K+ Annual Bonus (10 %)

Full Benefits: Medical, Vision, Dental, 15 days’ vacation/Sick time, 10 - Holidays, 401k (match up to 4%).

Company Info:

Our client is a growing company in the Pharmaceutical Industry. They are a part of a global parent company with sites in many countries with around 1,300 people at this site in Spokane, WA.

This is an integrated contract development and manufacturing organization (CDMO) offering specialized Aseptic Sterile manufacturing, filling and lyophilization of drug products in Vials.

Group Info: Be part of the Plant Technical Services Group of around 20 technical staff. This group has 2 sections supporting New Product Introductions – NPI & existing commercially manufactured products

Note 1: The company recently completed their 3rd state-of-the-art Sterile Liquid compounding & Vial Filling line and are currently expanding again with a 4th line at this growing plant site.

Note 2: This is a permanent direct Hire role. The client will transfer existing H1B and support future Green Card applications.

Job Summary:

The Senior Process Engineer provides expertise primarily in the areas of pharmaceutical process engineering and technical transfer.

This position will support large scale projects and multi-disciplinary teams.

The process engineer will also provide technical direction for complex projects and exhibit superior communication skills with all levels of employees.

The individual will be responsible for refining department and site processes and provide leadership and guidance to others.

Level Specific Expectations

• 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.

Job Functions

• 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.

Candidate Must Have:

• 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.
• Experience with Pharma sterile aseptic manufacturing, filling, Lyophilization
• Ability to work independently in a fast-paced CDMO environment.

Candidate Nice to Have:

• BS in Biology, Chemistry, Physics, or Engineering
• 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 Principals.
• Experience handling Change Control and CAPA situations
• Ability to grow into a Subject Matter Expert (SME) for Manufacturing & Process unit Operations
• Process Validation Experience

Keywords: Process engineer, technical services, Project Manager, Manufacturing support, Pharma, CDMO, plant, FDA, GMP, Sterile Aseptic liquid filling, contract Manufacturing, Lean Manufacturing, CAPA, Change control, NPI