Senior Engineer, Projects

Initial Therapeutics, Inc.; Holly Springs (NC); On-site; USD 80,000 - 120,000; Full time

Job summary

An innovative firm is seeking a Senior Engineer to join their Facilities & Engineering team. In this role, you will be pivotal in designing and qualifying systems for drug production, ensuring compliance with industry standards. You will collaborate with a dynamic team to implement engineering solutions that enhance operational efficiency and safety. This position offers the opportunity to make a significant impact on patient care while advancing your career in a collaborative, science-driven environment. If you are passionate about engineering and improving lives, this role is perfect for you.

Benefits

Competitive Benefits

Professional Growth Opportunities

Collaborative Culture

Qualifications

• 12+ years of engineering experience or equivalent education.
• Experience in Biopharmaceutical operations/manufacturing environment.

Responsibilities

• Lead engineering improvements for drug substance production.
• Ensure compliance with GMP and safety regulations.

Skills

Engineering Experience

Problem Solving

Data Analytics

Leadership

Communication Skills

Education

Bachelors in Chemical or Mechanical Engineering

Masters in Engineering

Tools

GMP Biopharmaceutical Production Equipment

Statistical Process Control

Root Cause Analysis

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Engineer, Projects

What you will do

Lets do this. Lets change the world. In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify equipment and systems needed for drug substance production as well as developing domain expertise to support operations upon start up.

• Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and qualification of equipment.
• Ensure systems are installed and operating safely and stay in sync with pertinent environmental health/safety practice, rules and regulations.
• Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors.
• Provide system guidance to identify performance risks and implement risk reduction strategies.
• Provide problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis, investigations, and implementation of corrective/preventive action.
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Developing and implementing testing strategies for new and existing equipment.
• Execute qualification protocols, including commissioning qualification test protocols (CQT).
• Ensuring that all equipment adheres to industry standards and regulations.
• Analyzing and documenting test results and completing reports.
• Working closely with other members of the engineering team to troubleshoot any issues with equipment functionality.
• Conducting regular audits of equipment to ensure ongoing compliance.
• Providing training and guidance to other staff on equipment validation processes.
• Collaborating with suppliers and manufacturers to understand the operation of new equipment and its qualification requirements

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Engineering experience OR
• Associates degree and 10 years of Engineering experience OR
• Bachelors degree and 6 years of Engineering experience OR
• Masters degree and 4 years of Engineering experience OR
• Doctorate degree and 2 years of Engineering experience

Preferred Qualifications:

• Bachelors degree in Chemical or Mechanical Engineering
• 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, viral filtration, tangential flow filtration as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
• General knowledge of plant utilities including plant steam, heating hot water, chillers, cooling towers, air compressors, and electrical systems
• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and the oversight of capital projects
• Understanding of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, commissioning and qualification
• Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
• Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
• Collaborative teammate prepared to work in and embrace a team based environment that relies on communication for effective decision-making
• Strong leadership, technical writing, and communication/presentation skills
• Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
• Ability for domestic/international travel

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.