Engineering Sr. Manager/Engineering Associate Director

Tableau Software•Spokane, WA

5d•$114,500 - $227,000•Onsite

About The Position

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.

Requirements

BS in: Mechanical Engineering, Pharmaceutical, Manufacturing, or Industrial Engineering required
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
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
12+ years in pharmaceutical engineering, with at least 3 years in aseptic filling equipment projects required.
5 years management technical personnel required

Nice To Haves

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
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

Responsibilities

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.
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.
Oversee equipment installation and integration into existing facilities.
Lead IQ/OQ/PQ activities in alignment with validation protocols and regulatory standards.
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.
Supervise and mentor a team of 10-15 technical engineers.
Foster a culture of safety, quality, and continuous improvement.
Quality, select and manage equipment suppliers and contractors.
Negotiate contracts and ensure timely delivery of equipment and services.