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.

The Capital Projects Manager ensures projects and related activities meet committed timelines and budgets to ensure these projects' compliance and requirements for on-time delivery. This position oversees a group of Project Managers, Project Engineers and other professional.  This position reports to the Director, Engineering and Technology. 

What you'll be doing:

• 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 senior level and other engineering professionals to support a variety of projects at the Bloomington, Indiana plant - projects support, but is not limited to, the following areas: facilities, utilities (critical and non-critical), aseptic processing, and filling & packaging equipment processes
• Oversees and develops departmental capital equipment budgets, Value Improvement Projects, and equipment/process optimization
• Ensures department compliance for master change control management and validation protocols
• Utilizes lean principles to manage the successful completion of departmental tasks within the boundaries of quality, time, safety and budget
• Manages project timelines associated with generating 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
• Leads the processes governing site master and long-range planning 

  
What you'll bring:

• Bachelor’s degree in an Engineering discipline, or equivalent experience, required (Advanced degree preferred)
• 8+years of experience in a pharmaceutical manufacturing environment
• Demonstrated effective leadership skills. 
• Must be self-motivated, have good interpersonal skills, and be capable of analyzing and solving complex problems through innovative thought and experience
• Knowledge of GMPs and regulatory guidelines
• MS Office Suite proficiency (Word, Excel, PowerPoint, Outlook)
• Experience using enterprise software (Autocad, JDE, BPLM, Pilgrim, Trackwise, Maximo etc.) 

 
Physical / Safety Requirements:

• 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

#IND-USOPS     #LI-TL1

Equal Employment Opportunity

Simtra 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.
                                                                                                                                                               
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