Job Description:
The Engineering Associate Director will lead a team of technical professionals responsible for the design, installation, qualification, and ongoing operational improvement of state-of-the-art aseptic filling equipment for liquid and lyophilized pharmaceutical products. This role ensures compliance with cGMP, regulatory requirements, and
Project Leadership:
- Manage end-to-end engineering projects for aseptic filling systems, isolators, lyophilizers, and component preparation equipment including concept design, procurement, installation, commissioning, and qualification.
- Develop and maintain project timelines, budgets, and resource plans.
Design & Specifications:
- Define technical requirements for filling lines, filling assemblies, isolators, lyophilizers, component preparation equipment, product and diluent vessels and associated SCADA components.
- Collaborate with cross-functional teams (Manufacturing, Quality, Validation) to ensure equipment meets process and regulatory needs.
Installation & Qualification:
- Oversee equipment installation and integration into existing facilities.
- Lead IQ/OQ/PQ activities in alignment with validation protocols and regulatory standards.
Compliance and Documentation:
- Ensure adherence to global regulatory requirements and guidelines for aseptic processing and regulatory standards.
- Prepare and review engineering documentation, including URS, FAT/SAT reports, and qualification protocols.
- Own equipment related deviation and CAPA investigation and remediation.
Team Management:
- Supervise and mentor a team of 10-15 technical engineers.
- Foster a culture of safety, quality, and continuous improvement.
Vendor Management:
- Quality, select and manage equipment suppliers and contractors.
- Negotiate contracts and ensure timely delivery of equipment and services. industry best practices while driving reliability, innovation and efficiency in sterile manufacturing operations.
Qualifications:
Required:
- BS in: Mechanical Engineering, Pharmaceutical, Manufacturing, or Industrial Engineering.
- 12+ years in pharmaceutical engineering, with at least 3 years in aseptic filling equipment projects.
- 5 years management technical personnel.
- Proven track record of on time equipment design, installation, and qualification under cGMP guidelines.
- Strong knowledge of aseptic processing, isolator technology, and lyophilization.
- Excellent project management, leadership, and communication skills.
- Deep knowledge of regulatory guidelines (FDA, EMA, ICH) and related industry guidelines such as ISPE.
- Ability to read and understand technical documents of all types such as CAD drawings, P&IDs, I&C documents, controls logic and hardware architecture
- Strong mentoring skills
- Office (Word, PowerPoint, Excel & SAP)
Preferred:
- ISPE GAMP Essentials
- ISPE Good Engineering Practices
- ISPE Biopharmaceutical Essentials
- Parenteral Drug Association Aseptic Processing
- Parenteral Drug Association Annex 1
- Parenteral Drug Association Manage your Isolator for Aseptic Processing
- PMI Project Management Professional
- ISA CAP
- Experience with automated filling lines and robotics.
- Knowledge of cleanroom design and environmental monitoring systems.
- Ability to manage multiple projects in a fast-paced environment.
Working Environment:
- Exposure to Allergens
- Working in Aseptic Areas
Location: Spokane, WA - On Site, Full‑Time Shift: Monday-Friday 8:00am-4:30pm
If you require assistance applying for a position, contact:
JHS‑TalentAcquisition@jubl.com