Engineering Sr. Manager​/Engineering Associate Director

Jubilant Hollister Stier LLC, Spokane's Largest Manufacturing Company, and well-established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant Hollister Stier is a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma.

Jubilant Hollister Stier is a proud member of the Jubilant Pharma family.

Our Promise:
Caring, Sharing, Growing

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.

Job Description:

The Engineering Sr. Manager/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 industry best practices while driving reliability, innovation and efficiency in sterile manufacturing operations.

* Project Leadership:

a. Manage end-to-end engineering projects for aseptic filling systems, isolators, lyophilizers, and component preparation equipment including concept design, procurement, installation, commissioning, and qualification.

b. Develop and maintain project timelines, budgets, and resource plans.

* Design & Specifications:

a. Define technical requirements for filling lines, filling assemblies, isolators, lyophilizers, component preparation equipment, product and diluent vessels and associated SCADA components.

b. Collaborate with cross-functional teams (Manufacturing, Quality, and Validation) to ensure equipment meets process and regulatory needs.

* Installation &

Qualification:

a. Oversee equipment installation and integration into existing facilities.

b. Lead IQ/OQ/PQ activities in alignment with validation protocols and regulatory standards.

* Compliance and Documentation:

a. Ensure adherence to global regulatory requirements and guidelines for aseptic processing and regulatory standards.

b. Prepare and review engineering documentation, including URS, FAT/SAT reports, and qualification protocols.

c. Own equipment related deviation and CAPA investigation and remediation.

* Team Management:

a. Supervise and mentor a team of 10-15 technical engineers.

b. Foster a culture of safety, quality, and continuous improvement.

* Vendor Management:

a. Quality, select and manage equipment suppliers and contractors.

b. Negotiate contracts and ensure timely delivery of equipment and services.

Qualifications:

* BS in:
Mechanical Engineering, Pharmaceutical, Manufacturing, or Industrial Engineering required

* ISPE GAMP Essentials desired

* ISPE Good Engineering Practices desired

* ISPE Biopharmaceutical Essentials desired

* Parenteral Drug Association Aseptic Processing desired

* Parenteral Drug Association Annex 1 desired

* Parenteral Drug Association Manage your Isolator for Aseptic Processing desired

* PMI Project Management Professional desired

* ISA CAP desired

* 8+ years in pharmaceutical engineering, with at least 3 years in aseptic filling equipment projects required

* 3 years management technical personnel required

* Proven track record of on time equipment design, installation, and qualification under cGMP guidelines required

* Experience with automated filling lines and robotics desired

* Knowledge of cleanroom design and environmental monitoring systems desired

* Ability to manage multiple projects in a fast-paced environment desired

* Strong knowledge of aseptic processing, isolator technology, and Lyophilization required

* Excellent project management, leadership, and communication skills required

* Deep knowledge of regulatory guidelines (FDA, EMA, ICH) and related industry guidelines such as ISPE required

* Ability to read and understand technical documents of all types such as CAD drawings, P&IDs, I&C documents, controls logic and hardware architecture required

* Strong mentoring skills required

* Working knowledge in Word, PowerPoint, Excel and SAP required

* Exposure to Allergens and working in Aseptic Area required

Engineering Associate Director (In addition to the above):

* 12+ years in pharmaceutical engineering, with at least 3 years in aseptic filling equipment projects required.

* 5 years management technical personnel required

Shift: Weekday days, Monday-Friday

Compensation & Benefits:

This is an on-site, full-time position located in Spokane, WA.

* Hiring Wage :( Engineering Sr. Manager): $114,500 - $183,200 annually depending on experience, with opportunity for growth, promotion and annual raises. Midpoint and above is reserved for employees who have longevity with Jubilant Hollister Stier…