Principal Engineer - Sterilization

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra?

Because we:
Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.
Make it RIGHT - We hold ourselves to a high standard of excellence,fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.
This role:
A Principal Engineer - Sterilization specializes in designing, installing, upgrading, commissioning and proper operation of sterilization equipment systems within a pharmaceutical manufacturing facility. This position reports directly to Director of Engineering & Technology.
The responsibilities:
Design and implement sterilization equipment systems to meet requirements and energy efficiency standards
Lead the installation/upgrade commissioning, qualification, and validation of new and current sterilization equipment systems (vials, autoclaves, depyrogenation, and terminal sterilizers)
Develop and implement maintenance programs to ensure optimal performance and reliability of sterilization equipment systems
Lead and participate in troubleshooting and diagnosing issues with sterilization equipment systems and develop solutions to resolve them efficiently and promptly
Conduct and oversee analysis and make recommendations regarding sterilization equipment, operations, controls, and components
Thought leader in industry trends, technologies, and best practices in sterilization equipment systems while coaching and training engineers and other technical staff
Identifies and drives new cost-saving opportunities to construct or remodel facilities to minimize long-term maintenance and repair costs
Key spokesperson for the Engineering & Technology group, and where appropriate, leads the collaboration with cross-functional teams, including project engineers, process engineers, quality assurance, technical services, and validation teams to ensure reliability and efficiency of sterilization equipment systems
Participates as subject matter expert (SME) during client or regulatory inspections and audits.
Leads risk assessments and implement mitigation strategies to ensure the integrity of sterilization equipment systems
Develop and maintain standard operating procedures (SOPS) of the operation and maintenance of sterilization equipment systems
Leads the commissioning and validation/qualification of sterilization equipment systems
Identify and drive process improvements and cost savings opportunities in sterilization equipment systems

Desirable qualifications:
BS degree in Mechanical Engineering, Chemical Engineering, or a related field
5-8 years' experience in Facilities, Equipment (autoclaves, dypyrogenation, terminal sterilizers), and Engineering in pharmaceutical manufacturing environments
3-5 years project management experience
Knowledge of regulatory requirements in the pharmaceutical, medical device, and/or food & beverage industries
Strong problem-solving skills and the ability to work in a team environment
Previous experience with deviation and change management systems
Working knowledge and experience of energy efficiency and sustainability practices of sterilization equipment systems
Excellent communication skills and the ability to work with cross-functional teams

In return, you'll be eligible for [1] :
Day One Benefits
Medical & Dental Coverage
Flexible Spending Accounts
Life and AD&D Insurance
Supplemental Life Insurance
Spouse Life Insurance
Child Life Insurance

Short and Long-Term Disability Insurance
401(k) Retirement Savings Plan with Company Match
Time Off Program

Paid Holidays
Paid Time Off
Paid Parental Leave and more

Adoption Reimbursement Program
Education Assistance Program
Employee Assistance Program
Community and Volunteer Service Program

Additional Benefits

Voluntary Insurance Benefits
Vision Coverage
Accident
Critical Illness
Hospital Indemnity Insurance
Identity Theft Protection
Legal and more

Onsite Campus Amenities

Workout Facility
Cafeteria
Credit Union

[1] Current benefit offerings are in effect through 12/31/24
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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