What are the responsibilities and job description for the Senior Project Engineer – Pharmaceutical Manufacturing & Process Engineering position at Homeland Talent Solutions?
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 assessments
- Provide 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
- 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
Benefits
The position offers a base salary of $103,050–$164,900 annually, with benefits beginning on the first day of employment. The comprehensive benefits package includes medical, dental, and vision coverage, FSA and HSA options, life and AD&D insurance, short- and long-term disability coverage, and an Employee Assistance Program. Employees also have opportunities for career growth and advancement, along with annual compensation reviews.
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. Apply today!
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.
Salary : $103,050 - $164,900