Engineer Senior

Pay 38-48/h depending on experience

Ideal Candidate: Experience: Biotech and pharma, GMP environment, manufacturing and tech transfer background, combination products.

Skills: Strong English written and verbal communication skills, MS Office, SmartSheet (project scheduling software), project management experience in a supporting role.

Desired: Engineering Background.

Key Responsibilities:

In this dynamic role, you will organize Technology Transfer activities for Final Drug Product (FDP) manufacturing.

Responsibilities include supporting and creating project schedules, lead site assessment and manufacturing capabilities, update project dashboards, and leading team meetings to progress the project towards final objectives. You will work across a global, cross-functional team consisting of manufacturing, device and packaging design for combination products, capital projects, physical test methods, quality, and regulatory team members.

Your role will focus on leading effective Tech Transfer projects for combination products, enhancing end-to-end controls with robust methods and data flow in a GMP setting.

Supporting New Product Introduction to our manufacturing site.

Owning documentation such as Project Plan, supporting engineering with Process Transfer Documents (PTD), protocols, and reports.

Supporting engineers with Make-a-Batch (M-a-B) activities to ensure sending/receiving site expectations are met.

Developing, tracking, and providing project dashboard updates.

Providing good communication plans to cross-functional teams and Process Engineer management.

Ability to apply project management and engineering science to production.

Strong teamwork and excellent interpersonal and communication skills.

Basic Qualifications:

Master's degree

OR Bachelor's degree and 2 years of experience

OR Associate's degree and 6 years of experience

OR High school diploma/GED and 8 years of experience

Preferred Experience:

Experience in the Tech Transfer of Combination Product field, focusing on project management and/or manufacturing.

Understanding of interdependencies of complex projects, especially involving new product introductions with new equipment/processes.

Knowledge of Combination Product design controls and regulatory requirements on a global scale.

Familiarity with the company's commercialization framework.

Program and Project Management skills (experience with MS Project, SmartSheets, and other project scheduling software is desired).

Additional Skills:

Proactive risk assessment, management, and mitigation.

Ability to lead and succeed in an ambiguous environment.

Strong project management skills.

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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