Process Specialist - Packaging

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.

The role:

The Process Specialist - Packaging provides technical support as a Subject Matter Expert for inspection, labeling & packaging operations with the goal of maximizing production efficiency. The position is visible on the packaging floor and has high interaction with the production team to identify opportunities for process improvement with a focus on equipment reliability. The position reports directly to the Operations Manager.

Its responsibilities:

• Develop a solid understanding of packaging processes/equipment - evolve into SME for assigned areas.
• As SME status achieved, serve as advisor to Building Leadership Team (BLT) relative to assigned equipment and processes.
• Develop a solid understanding of Lean/Six Sigma tools: SPC, CPK, Statistics, Pareto, Fishbone, 5-Why's, 6S, etc. Utilize these tools to drive improvements in overall equipment effectiveness.
• Participate in cross functional continuous improvement initiatives that directly impact operations performance.
• Review process trends to identify areas of improvements, including: equipment downtime (PM's, spare parts, equipment/tooling design), operator efficiency (set-up, tear-down, overall batch run speed) and product yield issues
• Responsible for standardization/training of set-up and basic troubleshooting procedures for Production Leadership and SME identified Operators.
• Will be process owner for specific systems or functions with the Packaging department
• Identify equipment requiring repair - initiate work order and support repairs through completion.
• Author technical documents, including SOPs, protocols, & nonconformance reports.
• Interact with auditors and regulatory authorities related to areas of process ownership.
• Participating member of new equipment installation projects. Ability to train packaging team members on new equipment and/or processes.

Desirable qualifications:

• Bachelor's degree with no experience, Associate's degree with 2 years' experience, or high school diploma with >5 years related manufacturing experience
• Understanding of Good Manufacturing Practices
• Computer proficiency in Word, Excel, and Outlook and the ability to use enterprise software, such as TcU, Maximo, Trackwise, etc.
• Must have the ability to work effectively in a "hands-on environment" capable of troubleshooting complex equipment and systems.
• Travel expectations: Minimal (1-2 weeks/year), related to new equipment purchases and qualifications.

Physical / safety requirements:

• Must be able to lift up to 50 lbs.
• Duties may require overtime work, including nights and weekends.
• Extended periods of standing and/or walking
• Use of hands and fingers to manipulate equipment is required.

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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