Senior Project Engineer – Pharmaceutical Manufacturing & Process Engineering

Homeland Talent Solutions; Spokane (WA); On-site; USD 103,000 - 165,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

FSA/HSA options

Life and AD&D insurance

Disability coverage

Employee Assistance Program

Job summary

Homeland Talent Solutions is partnering with a leading pharmaceutical manufacturer in Spokane, WA to identify a Senior Project Engineer for Pharmaceutical Manufacturing & Process Engineering. This role provides senior technical leadership across sterile manufacturing environments, overseeing capital projects and process optimization.

The ideal candidate has a strong background in project and process engineering within GMP/aseptic environments, plus experience with validation, URS/FRS/DDS, and

Qualifications

• Bachelor of Science in Mechanical Engineering, Chemical Engineering, Bioengineering, or related discipline.
• 5–10 years of pharma/FDA-regulated industry experience.
• Demonstrated project engineering and project management experience.
• Prior leadership or supervisory experience.
• Strong communication and cross-functional leadership skills.
• Ability to work in highly regulated manufacturing environments.
• Experience with sterile/manufacturing systems is preferred.

Responsibilities

• Provide technical leadership for manufacturing and process engineering projects, including facility expansion and capital projects.
• Design, optimize, and implement manufacturing processes to improve efficiency and quality.
• Develop and track process metrics to assess stability and risks.
• Support GMP, USP, FDA, EMA, and regulatory standards compliance.
• Own technical specification development (URS, FRS, DDS, RFQs) for contractors and partners.
• Develop and execute validation studies for new processes.
• Lead or support CAPAs and continuous improvement initiatives.
• Provide technical oversight for cleanrooms and aseptic processing.

Skills

Project leadership

Project management

Cross-functional leadership

Communication

Education

Bachelor of Science in Mechanical Engineering

Tools

URS/FRS/DDS RFQs

Job description

Homeland Talent Solutions is partnering with a leading pharmaceutical manufacturing organization in Spokane, WA to identify a Senior Project Engineer - Pharmaceutical Manufacturing & Process Engineering. This is an opportunity to provide senior-level technical leadership within a highly regulated environment supporting sterile pharmaceutical manufacturing. The Senior Project Engineer - Pharmaceutical Manufacturing & Process Engineering will lead complex engineering and capital projects while providing expertise across pharmaceutical manufacturing processes, equipment, validation, aseptic operations, and process optimization.

This role will collaborate with multidisciplinary teams to design, improve, and implement manufacturing processes and systems that support safe, efficient, and compliant sterile production.

The ideal Senior Project Engineer - Pharmaceutical Manufacturing & Process Engineering candidate will bring a strong background in project engineering, process engineering, GMP, aseptic manufacturing, validation, and technical leadership, along with the ability to successfully manage complex projects from concept through implementation.

Responsibilities

• Provide technical leadership for manufacturing and process engineering projects, including facility expansion, process improvement, compliance upgrades, cost reduction, and capital projects
• Design, optimize, and implement manufacturing processes to improve efficiency, quality, robustness, and sustainability
• Evaluate existing processes and workflows and identify opportunities for improvement
• Develop and track process metrics to assess process stability and identify performance risks
• Support and maintain compliance with cGMP, USP, FDA, EMA, and applicable global regulatory standards
• Support end-to-end product lifecycle activities from initial project quotation through product retirement
• Own technical specification development, including URS, FRS, DDS, and RFQs for contractors, OEMs, and engineering partners
• Develop and execute validation studies for new and improved manufacturing processes
• Analyze validation and process data and generate technical reports supporting qualification and process decisions
• Evaluate cross-functional data trends and identify risks to sterile product integrity
• Lead or support proactive CAPAs and continuous improvement initiatives
• Participate in deviation investigations and technical impact assessmentsProvide technical oversight for cleanroom classifications and aseptic processing, including sterilization, depyrogenation, media fills, and environmental controls
• Lead multidisciplinary project teams and influence outcomes without direct authority
• Support regulatory inspections, client audits, and technical reviews
• Provide technical guidance and mentorship to engineering and cross-functional team members

Requirements

• Bachelor of Science degree in Mechanical Engineering, Chemical Engineering, Bioengineering, or a related engineering discipline
• 5-10 years of related pharmaceutical or FDA-regulated industry experience
• Demonstrated project engineering and project management experience
• Prior leadership or supervisory experience
• Strong communication, technical problem-solving, and cross-functional leadership skills
• Ability to work effectively within highly regulated manufacturing environments
• Pharmaceutical manufacturing experience, preferred
• Aseptic manufacturing experience, preferred
• Fill-finish experience, preferred
• Process engineering and process optimization experience, preferred
• Validation and qualification experience, preferred
• Statistical analysis, preferred
• Lean Six Sigma, preferred
• Experience with URS, FRS, DDS, technical RFQs, CAPA, deviations, and process investigations, preferred
• Experience interacting with inspectors, auditors, customers, vendors, and external engineering partners, preferred
• Experience with sterile manufacturing systems, including: Cleanrooms, Sterilization, Depyrogenation, Media fills, Environmental controls, and Process validation, preferred

The position offers a base salary of $103,050-$164,900 annually, with benefits beginning on the first day of employment. Employees also have opportunities for career growth and advancement, along with annual compensation reviews.

Benefits

• medical coverage
• dental coverage
• vision coverage
• FSA and HSA options
• life and AD&D insurance
• short- and long-term disability coverage
• Employee Assistance Program

Summary

This is an exciting opportunity to take meaningful ownership of pharmaceutical manufacturing processes and engineering projects within a growing sterile manufacturing operation. The Senior Project Engineer will collaborate across Engineering, Manufacturing, Quality, Validation, and Operations to improve processes, support expansion, and help deliver reliable, compliant commercial manufacturing.

EEO Notice

Homeland LLC is an Equal Opportunity Employer. Homeland LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Homeland LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. Reasonable accommodation is available for qualified individuals with disabilities, upon request.