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Management Recruiters of Edison · 9 hours ago

Engineering Sr. Manager / Associate Director – Pharma Aseptic Filling

Spokane, WA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$215K/yr - $215K/yr

8+ years exp

Management Recruiters of Edison is representing a global BioPharma CDMO company seeking a Sr. Manager of Engineering for their expanding plant in WA state. The role involves leading a team responsible for the design, installation, qualification, and improvement of aseptic filling equipment while ensuring compliance with regulatory standards.

Staffing & Recruiting

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, 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 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

Pharmaceutical EngineeringAseptic FillingEngineering ManagementAutomation (Rockwell PLC/HMI/SCADA)CGMP ComplianceProject ManagementVendor ManagementContinuous ImprovementRegulatory StandardsTeam Leadership

Required

Bachelor's degree in a technical & related field

8+ years in pharmaceutical engineering

3+ years in pharmaceutical aseptic filling

3+ years of Engineering Department Management experience

Ability to work in a fast-paced Pharma contract Manufacturing organization (CDMO)

Preferred

Bachelor's degree in Engineering - Mechanical, Manufacturing, Industrial, Pharmaceutical

Advanced degree in Engineering or MBA

PMI certification in Project Management Professional – PMP

Professional Engineer – PE License

Automation experience using Rockwell PLC/HMI/SCADA systems

Experience working in a fast-paced Pharma Contract Manufacturing Organization (CDMO)

Certifications in any of the following: 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