Director Biomedical Engineering Jobs in Bothell, WA

Job Title: Senior Manager, Manufacturing Compliance

Location: Redmond, and Seattle, WA
Department: Site MSAT Manufacturing Compliance
Reports To: Director, Site MSAT

About Us: this is who we are

At Just Evotec Biologics, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what's possible. We're on a mission to create a place where curiosity isn't just encouraged-it's celebrated.

Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you!

The Role: / your challenge, ...in our journey

We're looking for a passionate and curious Senior Manager, Manufacturing Compliance to join our team. If you're excited by new challenges, solving complex problems, collaborative work and learning every step of the way, you might just be the perfect fit.

As a Senior Manager, Manufacturing Compliance at Just Evotec Biologics, you will guide the successful logistical support for quality records for clinical and commercial manufacturing operations while ensuring cGMP compliance. This position is responsible for supervising a team of technical subject matter experts in biologics operations.

What You'll Do:

• Guide investigations, demonstrate strong technical and problem-solving skills, and excellent technical writing skills

• Support team in tracking to deviation closure deliverables to meet lot disposition timelines.

• Improve the technical capabilities and quality practices within the department

• Coordinate activities and resolve issues across the department, other groups, and/or projects

• Ensure response to and/or resolve recurring technical or processing issues

• Drive safety, quality and accountability culture

• Communicate information effectively through updates, reports, and summaries

• Lead improvements in processes and methods that reinforce cGMP within the department and/or across the site

• Participate directly in internal, external, and global health authority audits/inspections

• Apply systematic thinking processes and technical knowledge to independently address a broad range of non-routine to moderately complex problems

• Establish goals of the department

• When appropriate, assist in providing leadership on project teams

• Provide routine updates on progress, status, and issues associated with campaigns/projects

• Provide support and/or direction to junior staff when necessary

• Exercise sound judgment when making decisions

• Make critical decisions in collaboration with key stakeholders

• Demonstrate accountability for personal, departmental, and organizational initiatives

Who You Are:

• BA / BS in a science or engineering related discipline (Biology, Chemistry, Biotechnology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Manufacturing, Process Engineering) with a minimum 10 years of experience in a GMP manufacturing environment

• Minimum 4 years of hands-on experience in fermentation, purification or pharmaceutical manufacturing process

• Minimum 4 years of managerial experience guiding teams in a GMP environment

• Proven knowledge of cGMP requirements to ensure compliance

• Experienced in handling major/critical deviations and leading complex investigations.

• Proven record of accomplishment managing, supervising and developing staff

• Candidate must possess strong focus on quality and attention to detail

• Possess effective task/time management organizational skills

• Capacity to develop solutions to technical issues of moderate scope

• Ability to organize, analyze/interpret, and effectively communicate data and results

• Motivated, self-starter with strong mechanical aptitude

• Good interpersonal, team, and communication skills are a must

• Strong proficiency in Microsoft Word, Excel, PowerPoint

• Familiar with other enterprise systems such as DeltaV, MES, and SAP

• Strong leadership, organizational, communication, technical and writing skills

• Experienced in presenting to internal and external stakeholders, auditors or inspectors.

Why Join Us:

• Growth Opportunities: We're a company that believes in continuous learning and development. Whether it's professional courses, mentorship, or new projects, we'll help you grow.

• Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life. This role is site based Redmond with visiting Seattle, WA.

• Inclusive Culture: We're committed to building a diverse and inclusive environment where everyone's voice is valued, and curiosity is encouraged.

• Innovative Projects: You'll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.

• A Place for Big Ideas: We don't just talk about thinking outside the box-we throw the box away. If you've got ideas, we want to hear them.

Are You Still Curious?

If you've read this far, then chances are you've got a curious mind-just like us. So, what are you waiting for? Take the leap and apply today. We can't wait to see where your curiosity leads you-and how it will shape the future of Just Evotec Biologics.

Let your curiosity guide your career-#BeCurious and explore the endless possibilities at Just Evotec Biologics!

The base pay range for this position at commencement of employment is expected to be $92,800 to $152,425 ; Base salary offered may vary depending on individual's skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.