Associate Director, Engineering

Join a Leader in Pharmaceutical Manufacturing - And Build What's Next

As Spokane's Largest Manufacturing Company, Jubilant Hollister Stier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support life changing medicines around the world.

We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant Hollister Stier is proudly part of the global, Jubilant Pharma family. established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support life changing medicines around the world.

For the Builders, Innovators, and Doers - This Is Your Place

If you are someone who thrives on solving complex problems, improving systems, and building real solutions, you'll feel at home here. At Jubilant Hollister Stier, your ideas matter - and your impact is felt globally.

Why builders choose us:

* Immediate impact:
Your work directly supports essential medicines and allergenic therapies used worldwide.

* Benefits start on day one:
Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because your well-being shouldn't have a waiting period.

* A career you can grow:
We provide opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity.

* A culture of improvement:
We value people who thrive on continuous improvement, innovation, and hands on contribution.

* A stable industry leader:
Backed by Jubilant Pharma, we pair long term stability with forward looking innovation.

If you want to build something meaningful with a team that values your drive, skills, and ideas - you belong here.

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

*…