Talent Job Seeker is Hiring a Manufacturing Process Specialist II Near Bloomington, IN
For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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.In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.Your role at Simtra BioPharma Solutions:The Process Specialist II provides technical/process support as a Subject Matter Expert for the manufacturing filling line operations with the goal of maximizing production efficiency. The position is visible on the manufacturing floor. It has high interaction with the production team to resolve issues during manufacturing. Drives improvements in overall process and equipment effectiveness (equipment availability, operator efficiency and product yield). What you’ll do:
Develop a solid understanding of filling line manufacturing processes / equipment – evolve into SME for assigned area. Equipment focus may cover syringe, vial or cartridge line / value stream, including component washer, depyrogenation tunnel, filling and stoppering machine, capper and tray loader. Preparation and operation of Lyophilizers is in scope of this position as well
As SME status achieved, serve as advisor to BLT relative to assigned equipment and processes
Develop a solid understanding Lean/Six Sigma tools: SPC, CPk, Statistics, Pareto, Fishbone, 5-Why’s, etc. Utilize these tools to drive improvements in overall equipment effectiveness
Participate in cross functional continuous improvement initiatives that directly impact operations performance
Participate in and/or author investigation/analysis of complex issues and determine root cause(s) and implement innovative, cost effective corrective actions to prevent recurrence
Support team deliverables for equipment related processes
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
Key member of the filling line Total Productive Maintenance (TPM) team
Ability to create, manage and approve Master Change Control, Equivalency Forms and Work Orders
Coach/mentor and train Maintenance Technicians and Production Operators
Bachelor’s Degree with a background in aseptic operations or >10 years related experience
Understanding of Good Manufacturing Practices
Computer proficiency in Word, Excel, and Outlook and the ability to use enterprise software, such as BPLM, Maximo, Trackwise, etc.
Must have the ability to work effectively in a ”hands on environment” capable of troubleshooting complex equipment and systems
Six Sigma Green Belt or Black Belt certification preferred; expectation will be to obtain at minimum a Green Belt certification.
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
Extended periods in Grade A, B, C, D production environments
Use of hands and fingers to manipulate equipment is required
#IND-USOPS Equal Employment OpportunitySimtra is 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. EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy Data PrivacyTo learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy