Senior Process Engineer - Clean Utilities - Design Specialist

BioSpace; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company in biotech is seeking a Senior Process Engineer specializing in Clean Utilities. This role involves designing and qualifying new systems for drug substance production, ensuring compliance with GMP regulations, and leading improvements in biopharmaceutical operations. The ideal candidate will possess strong problem-solving and leadership skills, with a focus on safety and regulatory compliance. Competitive benefits and flexible work options are offered.

Benefits

Health plans

Retirement plans

Bonuses

Stock incentives

Flexible time off

Remote/hybrid work options

Qualifications

• Doctorate or Bachelor's with relevant engineering experience required.
• 6+ years experience in biopharmaceutical operations preferred.

Responsibilities

• Provide system ownership for biopharmaceutical process equipment.
• Ensure systems comply with GMP requirements.
• Support troubleshooting to minimize production downtime.

Skills

Problem Solving

Communication

Leadership

Education

Doctorate degree

Bachelor's in Chemical or Mechanical Engineering

Tools

GMP systems

Six Sigma

Job description

Senior Process Engineer - Clean Utilities - Design Specialist

Join to apply for the Senior Process Engineer - Clean Utilities - Design Specialist role at BioSpace.

Since 1980, we have pioneered biotech to fight serious diseases, focusing on Oncology, Inflammation, General Medicine, and Rare Diseases, impacting millions of patients annually. Join us to make a lasting impact on patients' lives through research, manufacturing, and delivering innovative medicines.

Job Description

Join Amgen's Mission of Serving Patients

In this role, you will be part of the Facilities & Engineering (F&E) group, working closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems for drug substance production, and develop expertise to support operations post-startup.

Responsibilities

1. Provide system ownership for biopharmaceutical process equipment, support and lead improvements, develop business cases, and support equipment design, construction, startup, and validation.
2. Develop maintenance programs, ensure availability of spare parts, and coordinate maintenance activities.
3. Ensure systems are installed and operate safely, complying with environmental health and safety regulations.
4. Oversee commissioning and qualification of systems in line with GMP requirements and interact with regulatory inspectors.
5. Identify performance risks and implement risk reduction strategies.
6. Support troubleshooting to minimize production downtime, leading root cause analysis and corrective actions.
7. Assist in new product/technology introductions through engineering assessments and modifications.

Qualifications

Basic Qualifications:

• Doctorate degree
• OR Masters degree + 3 years engineering experience
• OR Bachelors degree + 5 years engineering experience
• OR Associates degree + 10 years engineering experience
• OR High school diploma/GED + 12 years engineering experience

Preferred Qualifications:

• Bachelor's in Chemical or Mechanical Engineering
• 6+ years relevant experience in biopharmaceutical operations
• Knowledge of GMP equipment/systems like autoclaves, CIP, washers, etc.
• Data-driven problem-solving skills (RCA, SPC, Six Sigma, etc.)
• Experience in regulated environments and GMP quality systems
• Engineering design and project oversight experience in GMP facilities
• Understanding of safety and regulatory compliance
• Strong communication, leadership, and organizational skills
• Flexibility for 24/7 support and travel

What We Offer

We support your growth with competitive benefits, including health plans, retirement plans, bonuses, stock incentives, flexible time off, and remote/hybrid work options.

Application Process

Apply at careers.amgen.com. We accept applications until the position is filled.

Amgen is committed to diversity and inclusion. We are an Equal Opportunity Employer and provide accommodations for applicants with disabilities.