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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 Process Engineering Manager ensures projects, protocols and planned activities meet committed timelines and budgets to ensure compliance and on-time delivery. This position oversees a group of Engineering professionals and Technicians. This position reports to the Director, Engineering.

The Responsibilities:

• Provides guidance, support, direction and leadership through positive interactions with all personnel during daily operations (24/7).
• Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans
• Manages a team of engineering professionals to support aseptic processing, filling and packaging equipment processes.,
• Oversee departmental capital equipment budgets, Value Improvement Projects, and equipment/process optimization.
• Ensures department compliance for master change control management and validation protocols.
• Utilize Lean principles to manage the successful completion of departmental tasks within the boundaries of quality, time, safety and budget.
• Responsible for overall management of project timelines associated with generating equipment design specifications, procurement, design of experiments, factory acceptance testing, installation, coordination of validation activities, standard operating procedure (SOP) generation, and transfer to functional area for in-service status.
• Provides guidance on design and technical direction to engineering staff.
• Provides review and approval of Engineering Work Orders, Master Change Controls, Exception Reports, Technical Summaries, Validation protocols, expense approvals and CAPA's.

Required Qualifications:

• Bachelors degree in Engineering discipline required
• Advanced degree preferred
• Minimum 10 years of experience in aseptic manufacturing
• Minimum 5 years supervisory experience
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements:

• Must be able to gown qualify for Grade A/B are
• Must be able to lift up to 50lbs.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting or standing for long hours.

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
  • 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
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • 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 12/31/26

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.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/