Process Engineering Manager

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:

We are seeking a Process Engineering Manager is responsible for leading a team of process engineers in the development, optimization, reliability, and implementation of manufacturing processes to improve efficiency, quality, and safety. The ideal candidate will have a strong background in process engineering management and team leadership, with a proven track record of collaborating with cross-functional teams to identify opportunities for process improvements and implementing reliability and robust solutions.

The responsibilities:

• Lead and manage a team of process engineers to develop and implement reliability programs and robust strategies for aseptic filling and packaging lines
• Develop Process Engineering team’s expertise to foster a culture of collaboration, inclusion, accountability, promoting teamwork and effective communication across all levels of the organization
• Establish and maintain key performance indicators to monitor equipment reliability, availability, and improvement effectiveness
• Collaborate closely with cross-functional teams, including engineering, operations, quality assurance, technical services, program management, and supply chain to ensure alignment and integration of processes
• Champion process improvement opportunities to streamline workflows and optimize the transfer of new products
• Develop and oversee budgets for process engineering projects, ensuring that resources are used
• Implement and maintain preventive maintenance programs to minimize equipment downtime and maximize production efficiency
• Ensure compliance with regulatory requirements and quality standards in all engineering activities and track and monitor successful and timely implementation and effectiveness of corrective actions and change controls
• Provide technical expertise, knowledge of engineering principles, and support to troubleshoot and resolve complex equipment and process challenges

Desirable qualifications:

• BS degree in Engineering or related field (including technology degree)
• 8+ years of experience in pharmaceutical manufacturing with a focus on reliability engineering, maintenance, or process engineering (preferably in a CDMO)
• Leadership experience in managing engineers and/or other technical individuals with the ability to develop and motivate a team
• In-depth knowledge of reliability engineering principles, methodologies, and best practices
• Strong project management skills with experience in leading and executing reliability improvement projects
• Excellent analytical and problem-solving skills, with the ability to apply data-driven approaches to drive continuous improvement
• Strong communication (oral and written) and interpersonal skills, with the ability to collaborate with cross-functional teams and communicate complex technical concepts to non-technical stakeholders

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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