Process Engineer - Solution Prep, Upstream, and Downstream

Initial Therapeutics, Inc.; Holly Springs (NC); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Competitive base salary

Comprehensive Total Rewards Plans

Job summary

Initial Therapeutics, Inc. is looking for a Facilities & Engineering professional to join their team in Holly Springs, NC. You will be responsible for designing, building, and qualifying equipment for drug substance production. The role involves ensuring compliance with GMP requirements and collaborating closely with corporate engineering.

Ideal candidates have a Bachelor’s degree in engineering, with a focus on chemical or mechanical disciplines, and 3+ years of relevant experience in biopharmaceutical manufacturing environments.

The position offers competitive compensation and the chance to be part of an innovative company dedicated to improving patient outcomes.

Qualifications

• Master’s degree or Bachelor’s degree and 2 years of engineering experience.
• 3+ years of relevant work experience in Biopharmaceutical operations.
• Knowledge of GMP Biopharmaceutical Production equipment.

Responsibilities

• Design, build, and qualify new systems for drug substance production.
• Support commissioning and qualification of manufacturing systems.
• Assist with engineering improvements and problem-solving.

Skills

Problem-solving

Technical writing

Collaboration

Communication

Data analysis

Education

Bachelor’s degree in Chemical or Mechanical Engineering

Tools

Data Analytics

Statistical Process Control

Six Sigma

Job description

Join Amgen’s mission of serving patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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 lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen’s newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best‑in‑class drug substance manufacturing technologies with embedded Industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen’s plan to be a carbon‑neutral company by 2027.

What You’ll Do

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 new equipment and systems needed for drug substance production as well as to develop domain expertise to support operations upon start‑up.

Site Design, Construction, Start‑up, and Operational Readiness

• Support the commissioning and qualification of manufacturing systems in alignment with GMP requirements and interact with regulatory inspectors.
• Ensure systems are installed, operate safely, and comply with pertinent environmental health/safety practice, rules, and regulations.
• Assist with new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Interact with regulatory inspectors as a manufacturing systems owner to communicate and demonstrate appropriate regulatory compliance of operating systems.

Site Operations

• Provide system support for biopharmaceutical process equipment. Assist in identifying and implementing engineering‑based improvements or upgrades to equipment or facility systems.
• Support the development of business cases for improvements, identification of design requirements, and translation of those requirements into process equipment/system design, specifications, and support the construction, startup, and validation of improvements.
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance activities to keep systems in proper working order.
• Provide system guidance to identify performance risks and implement risk‑reduction strategies.
• Provide problem‑solving support to reduce production downtime, including technical root‑cause analysis and implementation of corrective/preventive actions.
• Provide rotational on‑call support and/or shift support based on business needs to ensure 24/7 day‑to‑day reliability of Solution Prep, Upstream, and Downstream systems for plant operations.
• On‑site and up to 10% domestic/international travel.

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 the following qualifications.

Basic Qualifications

• Master’s degree
• OR Bachelor’s degree and 2 years of engineering experience
• OR Associate’s degree and 6 years of engineering experience
• OR High school diploma/GED and 8 years of engineering experience

Preferred Qualifications

• Bachelor’s degree in Chemical or Mechanical Engineering or similar engineering discipline.
• 3 + years of relevant work experience with 2 + years of experience in Biopharmaceutical operations/manufacturing environment.
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems with direct experience with Solution Prep, Upstream, and Downstream purification equipment such as weigh and dispense equipment, solution preparation vessels, cell culture reactors, centrifugation, chromatography, viral filtration skids, UF/DF skids, and other equipment needed to support these processes such as autoclaves, CIP systems, washers, clean steam, water for injection, etc.
• 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, Statistical Process Control, Six Sigma, Predictive Maintenance).
• Experience working in a regulated environment (e.g., cGMP, OSHA, EPA) and familiarity with GMP quality systems/processes such as change control, non‑conformances, corrective and preventive 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, and validation.
• 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

We support your professional and personal growth and well‑being. In addition to a competitive base salary, Amgen offers competitive and comprehensive Total Rewards Plans aligned with local industry standards.

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.