Sterile Engineer

$104,000 - $124,800/Yr

Actalent - Shawnee, KS

Full-time - Mid Level

Remote - Shawnee, KS

10,001+ employees

Administrative and Support Services

About the position

The Sterile Engineer position at Actalent focuses on aseptic processing and sterile suspensions, playing a vital role in new product development. The role requires collaboration with engineering and cross-functional teams to ensure compliance with standards and successful project outcomes.

Responsibilities

• Lead aseptic processing and sterile suspension projects, ensuring compliance with all relevant standards and regulations.
• Conduct media fills and validate sterile suspension processes to maintain product sterility.
• Support technology transfer activities and contribute to new product development efforts.
• Work closely with the engineering team and other departments to ensure seamless project execution.
• Provide technical expertise in sterile compounding and aseptic techniques.
• Develop and implement protocols for sterility testing and the use of sterilizing grade filters.
• Maintain detailed documentation of processes and project progress.

Requirements

• Degree in Chemical, Mechanical, or Biomedical Engineering; advanced degree preferred.
• Experience in aseptic processing and sterile suspensions is required.
• Strong experience in BHP qualifications and media fills.
• Experience with Steam and Place Cycles.
• Proven track record in supporting technology transfer and new product development.
• Excellent problem-solving skills and attention to detail.
• Ability to work collaboratively with cross-functional teams and communicate effectively.
• Experience with sterility testing and sterilizing grade filters.
• Sterile Suspension experience is a must.
• Knowledge of regulatory requirements for sterile pharmaceutical products.
• Strong organizational and communication skills.

Nice-to-haves

• Project engineering experience in the chemical, pharmaceutical, or process improvement fields.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)