Senior Process Engineer - Solution Prep, Upstream, and Downstream

Initial Therapeutics, Inc.; Holly Springs (NC); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Comprehensive Total Rewards Plans

Equal Opportunity Employment

Job summary

Initial Therapeutics, Inc. in Holly Springs, NC is looking for a Senior Process Engineer specializing in Solution Prep, Upstream, and Downstream processes. The ideal candidate will drive engineering excellence by designing manufacturing systems, ensuring regulatory compliance, and leading cross-functional collaborations. A Doctorate or relevant engineering degree with substantial biopharmaceutical experience is required.

This role entails responsibilities like equipment design, factory testing, and providing technical support, while also offering opportunities for leadership in a dynamic environment.

Qualifications

• Doctorate degree or equivalent experience in engineering.
• Experience in biopharmaceutical operations, with 5+ years in a manufacturing environment.
• Strong knowledge of process equipment and troubleshooting in GMP facilities.

Responsibilities

• Design and build manufacturing equipment systems.
• Collaborate with key customers for reliable plant operations.
• Lead technical root cause analysis and implement corrective actions.

Skills

Problem-solving

Process Engineering

Technical Writing

Leadership

Communication

Education

Degree in Chemical or Mechanical Engineering

Doctorate or Master's degree

Bachelor's degree

High school diploma / GED

Tools

GMP Quality Systems

Engineering Software

Job description

Senior Process Engineer – Solution Prep, Upstream and Downstream

What you will do

• Support the design and build of manufacturing equipment systems by aligning design review processes and documents with site requirements, including equipment design and sizing, architecture and electrical distribution, and piping and instrumentation diagrams.
• Support factory acceptance testing working in partnership with global engineering during site installation, including reviewing protocols and resolving punch list items.
• Work with capital project team to ensure systems are installed and operating safely, comply with pertinent environmental health/safety practice, rules and regulations, and Amgen global engineering requirements. Ensure that systems are installed per the design requirements.
• Execute and guide the commissioning and validation of systems to ensure their operational capability is aligned with manufacturing requirements, GMP regulation, and on-time project delivery. Support execution of engineering and performance qualification runs while providing hypercare support as needed.
• Perform engineering assessments for plant equipment operations, implementing equipment modifications, and supporting engineering runs in support of new product/technology introductions as required.

Site Operations

• Responsible system owner for Solution Prep, Upstream and Downstream Drug substance process equipment, areas, and systems, providing end‑to‑end support for operations.
• Effectively collaborate with key customers and support groups (e.g., Manufacturing, Quality, Process Development, Maintenance, network partners) to ensure reliable plant operations.
• Work with original equipment manufacturers for breakdown and planned maintenance of process equipment as applicable.
• Lead identifying and implementing engineering‑based improvements or upgrades to process equipment systems. This may include developing business cases for improvements, identifying design requirements, and translating these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of equipment.
• Develop master maintenance programs for equipment, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order.
• Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for the process equipment.
• Provide technical mastery and problem‑solving leadership to proactively reduce production downtime. This includes leading technical root cause analysis and implementation of corrective/preventive actions for families of systems.
• Lead new product/technology introductions by performing engineering assessments, equipment performance risk assessments, identifying gaps and owning their remediation, implementing equipment modifications, and supporting engineering runs.
• Provide rotational on‑call support and/or shift support based on business needs to ensure 24x7 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 these qualifications.

Basic Qualifications

• Doctorate degree
• Masters degree and 2 years of Engineering experience
• Bachelor’s degree and 4 years of Engineering experience
• Associate’s degree and 8 years of Engineering experience
• High school diploma / GED and 10 years of Engineering experience

Preferred Qualifications

• Degree in Chemical or Mechanical Engineering or similar engineering discipline.
• 6+ years of relevant work experience with 5+ 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, and UF/DF skids 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.
• Experience with Tech Transfer, Process Design, and Commissioning & Qualification.
• 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.
• 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.
• Strong leadership, technical writing, and communication/presentation skills.
• Work schedule flexibility as required to support 24/7 operations.
• Ability for domestic/international travel.

What you can expect of us

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

Equal Opportunity Employer & Accommodation

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.