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Jubilant Pharma Limited · 9 hours ago

Engineering Sr. Manager/Engineering Associate Director

Spokane, WA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$114K/yr - $183K/yr

8+ years exp

Jubilant HollisterStier LLC, Spokane’s Largest Manufacturing Company, is seeking an Engineering Sr. Manager/Engineering Associate Director to lead a team of technical professionals in the design and operational improvement of aseptic filling equipment for pharmaceutical products. The role involves managing engineering projects, ensuring compliance with regulatory standards, and fostering a culture of safety and continuous improvement within the team.

Health CareManufacturingPharmaceutical

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

Qualification

Aseptic processingPharmaceutical engineeringRegulatory guidelinesProject managementMechanical EngineeringLyophilizationCleanroom designAutomated filling linesWordPowerPointExcelVendor managementLeadership skillsCommunication skillsMentoring skillsTeam management

Required

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

Preferred

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

Benefits

Medical, Dental, Vision, Flexible Spending and Health Savings Accounts

Life, AD&D, Short and Long Term Disability

401(k) with company match

Generous paid time off plan

Employee Assistance Program

Company

Jubilant Pharma Limited

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to our customers across geographies.

Founded in 2014

Singapore, Central Region, SGP

1001-5000 employees