Engineering Sr. Manager / Associate Director – Pharma Aseptic Filling

Management Recruiters of Edison; Spokane (WA); On-site; USD 215,000 - 250,000; Full time

Benefits offered by this job

Medical, Vision, Dental benefits

15 days vacation/Sick time

10 Holidays

401k with up to 4% match

Relocation Bonus

Job summary

A pharmaceutical manufacturing firm is seeking a Sr. Manager of Engineering to oversee engineering projects for aseptic filling systems at their Spokane, WA facility. This role involves managing a team of 10 engineers while ensuring compliance with cGMP and regulatory standards. Ideal candidates have over 8 years in pharmaceutical engineering, strong management experience, and a Bachelor's degree in a related technical field. Total compensation can exceed $250K, including benefits and relocation assistance.

Qualifications

• 8+ years in pharmaceutical engineering.
• 3+ years in pharmaceutical aseptic filling.
• 3+ years of Engineering Department Management experience.

Responsibilities

• Manage engineering projects for aseptic filling systems.
• Define technical requirements for filling lines and associated equipment.
• Ensure compliance with global regulatory requirements.

Skills

Pharmaceutical engineering

Aseptic filling

Engineering department management

Project management

Team management

Education

Bachelor's degree in a technical field

Tools

Rockwell PLC/HMI/SCADA systems

Job description

Our client – a global and growing BioPharma CDMO company needs a Sr. Manager of Engineering at their expanding plant in WA state, Excellent total comp. up to $250K+ with good Benefits + Relocation Bonus.

Job Posting # 2699R

Job Title

Engineering Sr. Manager / Associate Director (See Note 3) – Pharma Aseptic Filling

Location

Spokane, WA Overnight Travel: 10%

Relocation

The client offers a lumpsum bonus for relo assistance.

Compensation

Salary range up to $215K base + Annual Bonus (15%)

Full Benefits

Medical, Vision, Dental, 15 days’ vacation/Sick time, 10 - Holidays, 401k (match up to 4%).

Company Info

Our client is a growing CDMO company in the Pharmaceutical Industry. They are a part of a global parent company with sites in many countries including around 1,300 people at this site in Spokane, WA.

Group Info

Lead the Engineering group supporting the existing and expansion site in Spokane, WA. The group will have around 10 engineers reporting to this role including Manufacturing Engineering, Automation, Project Engineers/Managers.

Note1

The company recently completed their 3rd state-of-the-art Sterile Liquid compounding & Vial Filling line and are currently expanding again with a 4th line at this site.

Note 2

This is a hands-on role and the manager is expected to lead the team by example and perform some strategic engineering work and also lead this group. He will report to the Sr. Director of Engineering.

Note 3

This role can be top graded to an Associate Director for the right person with this level of experience

Summary

The Sr. Engineering 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.

Job Description

• 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, 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.
• Compliance and Documentation:
• 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.
• Team Management:
• 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.

Candidate Must Have

• 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)

Candidate Nice to Have

• 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 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

Keywords

Projects, Assoc Director, engineering, Pharma, CDMO, manufacturing, plant, FDA, GMP, Sterile Aseptic liquid filling, Isolators, Clean rooms, Lyophilization, contract Manufacturing, Manager, PE, PMP