Job Description: The
Associate Director, Engineering 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 industry best practices while driving reliability, innovation and efficiency in sterile manufacturing operations.
- Project Leadership:
- Manage end-to-end engineering projects for aseptic filling systems, isolators, lyophilizers, and component preperation 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 preperation 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.
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- -TimeShift: Weekday DaysCompensation & Benefits That Start on Day One - Because Your Well Being Matters Hiring Wage: $141,900 - 227,000 annually + 15% annual bonus, with opportunities for growth, promotion, and annual raises.
At Jubilant HollisterStier, we don't believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.
Starting on your first day, you receive:- Medical, Dental & Vision coverage
- Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
- Life & AD&D Insurance
- Short-Term & Long-Term Disability Insurance
- Employee Assistance Program
Unlock Your PotentialIf you're seeking a dynamic and rewarding career, we welcome your application today. Apply online:
Careers - Jubilant HollisterStier
