Sr. Engineer Process Development

Amgen; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a Process Engineer to join their dynamic team in the United States. This role is pivotal in providing technical expertise in sterile drug product operations, including formulation and filling processes. The successful candidate will lead investigations, support new product introductions, and drive continuous improvement initiatives. Ideal candidates will possess strong problem-solving skills and demonstrate leadership potential, thriving in a fast-paced environment. Join this innovative firm and contribute to advancing drug product development while collaborating with cross-functional teams to enhance productivity and process capability.

Qualifications

• 6+ years experience in drug product formulation and filling operations.
• Strong leadership capabilities and ability to guide teams.

Responsibilities

• Provide technical expertise in sterile drug product unit operations.
• Lead product and process investigations and continuous improvement initiatives.

Skills

Technical Expertise in Sterile Drug Product Operations

Problem-Solving Skills

Leadership Skills

Data Analysis

Education

Bachelor’s or Master’s degree in Engineering or Science

PhD in a related discipline

Tools

GMP Documentation

Job description

Career Category Engineering Job Description

Description:

Process Engineer required to work within the Process Development Commercial Support team based in Amgen Dun Laoghaire (ADL). The team is responsible for providing process and product support to drug product formulation and fill-finish operations in ADL as drug product process SMEs.

Your core responsibilities will include:

• Providing technical expertise in sterile drug product unit operations such as formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping.
• Leading or contributing significantly to product and process investigations, including root cause analysis and product impact assessments.
• Acting as a subject matter expert during change control, assessing the impact of proposed changes on the product and process performance.
• Supporting new product introductions (NPI), including recipe and protocol development, batch execution support and troubleshooting.
• Driving continuous improvement initiatives to enhance process capability, reduce variability and improve productivity.
• Analysing manufacturing data trends to identify opportunities for improvement and prevent potential issues.
• Reviewing and approving GMP documentation such as SOPs, electronic batch records, and product technical documentation.
• Collaborating with cross-functional and global teams to ensure alignment and execution of strategies with potential for advancement in network roles such as Drug Product Team Lead etc.

What we expect of you

We’re looking for a senior-level engineer who not only brings strong technical expertise but also shows potential for leadership. You should be energized by problem-solving in a fast-paced environment and be comfortable making decisions based on data and sound technical rationale. You should have the ability to translate technical knowledge into clear risk-based decisions and communicate effectively across functions.

Basic Qualifications:

• Bachelor’s or Masters degree in Engineering, Science or related discipline with 6 years experience in a similar role OR PhD and 4 years of directly related experience.
• Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external

Preferred Qualifications

• Typically 6+ years of drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling or lyophilisation.
• Strong leadership capabilities, with experience guiding teams or technical initiatives.
• Demonstrated experience in parenteral drug product manufacturing and delivery of cross functional, complex technical projects.
• Strong problem-solving technical skills related to parenteral drug product manufacturing.
• Thorough knowledge of GMP biotechnology manufacturing, with a significant understanding and knowledge of cGMPs. Experience with regulatory agency audits is beneficial.

.