Sr. Engineering Manager

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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.

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.

The Engineering Sr. Manager 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 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, and 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.
• 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.

• 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 of 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…