Biologics Manufacturing Engineer – Seattle, WA

Are you a skilled engineer passionate about advancing biologics manufacturing? We are seeking a Biologics Manufacturing Engineer to join our cutting-edge team in Seattle, WA. This role offers a unique opportunity to contribute to the development and optimization of biopharmaceutical production processes in a fast-growing, innovative environment. If you excel at problem-solving, process improvement, and cross-functional collaboration, this position is for you.

Drive Innovation in Biologics Manufacturing

Join a leading biopharmaceutical company based in Seattle, WA, focused on developing and delivering high-quality biologic therapies. As a Biologics Manufacturing Engineer, you will play a critical role in scaling up manufacturing processes, ensuring compliance with industry standards, and enhancing production efficiency. The ideal candidate will have hands-on experience in bioprocess engineering, a strong understanding of GMP, and a commitment to continuous improvement. This is your chance to impact patient lives by supporting the production of life-saving biologics.

Key Responsibilities of the Biologics Manufacturing Engineer – Seattle, WA

Process Development & Optimization: Lead efforts to develop, optimize, and scale biologics manufacturing processes, ensuring they are robust, efficient, and compliant with regulatory standards. Collaborate with R&D and Quality teams to transfer processes from development to commercial manufacturing.

Manufacturing Support & Troubleshooting: Provide technical expertise and hands-on support during manufacturing campaigns. Identify, investigate, and resolve process deviations, equipment issues, and production bottlenecks to maintain smooth operations and maximize yield.

Technology Transfer & Scale-Up: Manage technology transfer activities between development labs and manufacturing facilities. Drive scale-up activities, ensuring processes remain consistent and meet predefined quality and productivity targets at commercial scale.

Regulatory Compliance & Documentation: Ensure manufacturing processes comply with cGMP regulations and internal quality standards. Prepare, review, and maintain detailed batch records, SOPs, and validation documentation in collaboration with Quality Assurance.

Cross-Functional Collaboration: Work closely with Manufacturing, Quality, Engineering, and Supply Chain teams to align process improvements with production schedules and business goals. Support continuous improvement initiatives aimed at enhancing process efficiency and reducing costs.

Data Analysis & Reporting: Collect, analyze, and interpret manufacturing process data to identify trends and areas for improvement. Provide timely reports and technical insights to stakeholders for informed decision-making.

Risk Management & Quality Control: Identify potential risks in the manufacturing process and implement mitigation strategies. Support quality control activities by ensuring process parameters are controlled and product quality attributes are consistently met.

Equipment & Facility Qualification Support: Assist in equipment qualification, validation, and maintenance activities to ensure manufacturing readiness and compliance. Participate in facility design and upgrades to support evolving manufacturing needs.

What the Client is Looking for in You

The client seeks a highly skilled and proactive Biologics Manufacturing Engineer who can drive the successful scale-up and manufacturing of biologic products while ensuring compliance, quality, and operational efficiency. You should be a detail-oriented problem solver with a passion for innovation and a collaborative mindset to work effectively across multiple teams in a regulated environment.

Proven Expertise in Biologics Manufacturing

The ideal candidate has strong hands-on experience in biologics manufacturing processes, including cell culture, purification, formulation, and fill-finish operations. You should have a track record of supporting process development and technology transfer from R&D to commercial scale, with a keen ability to troubleshoot and optimize complex bioprocess workflows. Experience with cGMP standards and regulatory requirements is essential.

Strong Technical and Analytical Skills

You must demonstrate proficiency in analyzing manufacturing data, identifying process variability, and implementing data-driven improvements. The client values candidates with strong problem-solving skills who can apply engineering principles and statistical tools to enhance process robustness, yield, and product quality.

Collaborative and Cross-Functional Team Player

Success in this role requires effective communication and teamwork with R&D scientists, quality assurance, validation, and manufacturing operations. The client seeks an engineer who can foster collaboration, share technical knowledge, and align process objectives with business goals to ensure seamless technology transfers and manufacturing readiness.

Commitment to Quality and Regulatory Compliance

A deep understanding of GMP regulations and quality systems is critical. You should be vigilant in maintaining compliance through accurate documentation, supporting audits, and driving continuous improvement initiatives that uphold the highest standards for product safety and efficacy.

Adaptability and Continuous Improvement Mindset

The biologics manufacturing landscape is fast-evolving, and the client values candidates who thrive in dynamic environments. You should be open to learning new technologies, applying Lean/Six Sigma methodologies, and championing innovative solutions that increase efficiency, reduce costs, and accelerate time-to-market.

Strong Organizational and Project Management Skills

Managing multiple priorities and coordinating cross-functional projects is key. The client seeks a Biologics Manufacturing Engineer who can independently manage timelines, communicate project status clearly, and ensure milestones are met without compromising quality or compliance.

FAQs About the Role – Biologics Manufacturing Engineer – Seattle, WA

What are the key responsibilities of the Biologics Manufacturing Engineer in this role?
As a Biologics Manufacturing Engineer, you will be responsible for developing, optimizing, and scaling up biologics manufacturing processes. You will support commercial production, troubleshoot process issues, ensure compliance with cGMP standards, and collaborate with cross-functional teams to improve product quality and manufacturing efficiency.
What qualifications and experience are required for this position?
The ideal candidate should have a degree in biochemical engineering, biotechnology, chemical engineering, or a related field, with relevant experience in biologics manufacturing. Hands-on experience with upstream and downstream bioprocessing, process scale-up, and familiarity with GMP regulations is essential. Experience in technology transfer, process validation, and data analysis is highly valued.
What technical skills are essential for this role?
Key technical skills include expertise in cell culture, fermentation, chromatography, filtration, and aseptic processing. Proficiency in troubleshooting manufacturing equipment, process control systems, and the ability to interpret process data are critical. Knowledge of Lean or Six Sigma methodologies for continuous improvement is a plus.
What kind of challenges can I expect in this role?
You will face challenges such as managing process variability, optimizing scale-up procedures, ensuring strict regulatory compliance, and minimizing production downtime. Coordinating across teams to implement process improvements and handling unexpected deviations during manufacturing runs are common challenges.
How does this role contribute to the company’s overall success?
Your work will directly impact the quality, safety, and availability of biologic therapies produced by the company. By improving manufacturing processes and ensuring regulatory compliance, you help accelerate product delivery to patients, increase production efficiency, and reduce costs—driving the company’s growth and reputation.
What is the company culture and work environment like?
The company promotes a collaborative, innovation-driven environment where scientific rigor and operational excellence are prioritized. You will be part of a diverse, multidisciplinary team dedicated to advancing biologic medicines. Continuous learning, teamwork, and adherence to high ethical standards are strongly encouraged.

What Remuneration Can You Expect from This Job?

As a Biologics Manufacturing Engineer based in Seattle, WA, you can expect a competitive compensation package that reflects your specialized skills in biopharmaceutical manufacturing. The remuneration for this role typically includes:

Base Salary
The base salary for a Biologics Manufacturing Engineer varies depending on experience, education, and company size. In the Seattle biotech market, the annual base salary generally ranges from $90,000 to $140,000, with senior-level engineers or those with specialized expertise earning towards the higher end.
Performance-Based Bonuses
Many companies offer annual performance bonuses tied to individual and team achievements, project milestones, and overall operational targets. These bonuses typically range from 5% to 15% of the base salary and serve to reward contributions to process improvements, productivity gains, and product quality.
Equity & Stock Options
Biotech and pharmaceutical firms often provide equity incentives such as stock options or restricted stock units (RSUs). These align your interests with the company’s long-term growth and innovation, potentially offering significant financial upside depending on company performance and market valuation.
Profit-Sharing & Long-Term Incentive Plans (LTIPs)
Some organizations provide profit-sharing or LTIPs to reward sustained contributions and loyalty. These plans encourage engineers to focus on continuous process enhancements and support the company’s strategic goals over several years.
Benefits & Perks
Comprehensive benefits packages typically include:

Health, dental, and vision insurance
Retirement savings plans such as 401(k) with company matching
Paid time off and holidays
Professional development opportunities and tuition reimbursement
Wellness programs and employee assistance services

Signing Bonuses & Relocation Assistance
For highly qualified candidates or those relocating to Seattle, companies may offer signing bonuses or relocation support. These one-time incentives can range from $5,000 to $20,000 depending on experience and company policy.

Total Compensation Potential

When combining base salary, bonuses, equity, and benefits, total annual compensation for a Biologics Manufacturing Engineer in Seattle typically ranges from $100,000 to $160,000 or more. Top-performing engineers in leading biotech firms may command packages at the higher end of this spectrum, reflecting their critical role in advancing biologics manufacturing.

How to Apply

If you are a detail-oriented and innovative engineer with experience in biologics manufacturing, we encourage you to apply for the Biologics Manufacturing Engineer position in Seattle, WA. This is an excellent opportunity to contribute to cutting-edge biopharmaceutical production, process optimization, and quality assurance in a dynamic and growing environment.

To apply, please submit your resume along with a cover letter outlining your experience in biologics manufacturing processes, process development, quality control, and cross-functional collaboration. Be sure to highlight your problem-solving skills, familiarity with regulatory standards, and your ability to improve manufacturing efficiency and product quality.

This role offers a rewarding career path where you can directly impact lifesaving biologic therapies and advance your professional expertise. Apply today to join a leading biotech company in Seattle and help drive innovation in biologics manufacturing!

For more information or to explore similar opportunities, visit our Biologics Recruiting Experts Page.

Job Category: Biologics

Job Type: Full Time

Job Location: Seattle

Biologics Manufacturing Engineer – Seattle, WA