Principal Quality Engineer

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:

The Principal Quality Engineer role is responsible for overseeing equipment and facility design, commissioning, qualification, and procedural development for large scale building projects. This role will collaborate with cross functional teams (Engineering, Manufacturing, Technical Services, etc.) to ensure compliance with global and industry standards for new projects and equipment onboarded at Simtra.

The responsibilities:

• Provides guidance and technical expertise in interpreting regulatory and Simtra requirements for equipment, cleanroom design and function, validation, and production processes.
• Ensures compliance with all worldwide regulatory agency requirements and company-specific regulations related to quality of product and employee safety.
• Primary quality contact responsible for quality oversight and approval of commissioning and qualification related to process and facility equipment including equipment IOPQ, sterility assurance, cleaning validation, and computer systems validation.
• Understands and applies equipment and facility industry standards and global regulations to design of cleanrooms and production processes and workflows.
• Collaborates with cross-functional team during design and implementation of new projects, equipment, and systems to provide quality oversight and implement risk management approached for quality by design.
• Approves and oversees change management documentation and workflow for new projects at Simtra
• Supports cross-functional teams in the maintenance and continuous improvement of established cleanrooms, critical systems, and production processes.
• Proficient in facility operations of classified areas including aseptic manufacturing processes.
• Identifies improvements and implement best practices for the quality engineering functions utilizing a risk based approach to ensure quality of product, reliability of systems, and process control.
• Subject Matter Expert (SME) and key participant in compliance audits and inquiries.
• Assists with timely closure of audit observations and CAPAs.
• Provides guidance and approval for nonconformance investigations (NCRs), and corrective actions.
• Drives continuous improvements within the quality organization and cross-functionally.
• Process owner for applicable quality systems and workflow.
• Reviews and approves equipment, production, and quality SOPs and other applicable documentation.
• Provides review and approval of work orders, preventive maintenance procedures, validation reviews, and related technical documentation.
• Interviews, coaches, and develops new employees within Quality Engineering, Engineering, and Quality Assurance Organization.

Desirable qualifications:

• B.S. in Engineering
• 5 years pharmaceutical related experience. Preferably in validation or equipment qualification
• Thorough understanding of global engineering and industry standards.
• Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
• Effectively operate in and may facilitate cross-functional teams with guidance.
• Must be able to provide solutions that reflect understanding business objectives and cost implications.
• Computer proficiency in Microsoft Office and the ability to use enterprise software, including: JDE, Veeva Vault, Trackwise, Maximo, etc.)

Physical / safety requirements:

• Duties may require overtime work, including nights and weekends
• Position may require sitting or standing for long hours.
• Must be able to gown qualify for Grade C and D production areas

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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