CAPEX Project Manager

Simtra US LLC; Bloomington (IN); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan

Time Off Program (Paid Holidays, PTO)

Paid Parental Leave

Job summary

Simtra BioPharma Solutions (Simtra) is seeking a CAPEX Project Manager to lead capital projects in our Bloomington, IN facility. You will ensure safe, on-time, on-budget execution in GMP-regulated environments, coordinating manufacturing, quality, EHSS, maintenance, validation, and procurement.

You will drive project strategy, risk planning, and documentation (URS, RFQs, CCMs, P&ID revisions) and partner with external engineers through design and CQV activities, turning concepts into validated

Qualifications

• Capital project execution from concept to commissioning.
• Knowledge of aseptic processing and packaging engineering best practices.
• Able to lead multiple projects simultaneously.
• Read mechanical, electrical, and P&ID drawings.
• Strong written and verbal communication skills.

Responsibilities

• Define project strategies, goals, and ensure scope, budgets, and schedules meet requirements.
• Maintain cross-functional communications across teams and stakeholders.
• Identify risks and develop risk plans with proactive mitigation.
• Manage conflicts and ensure successful project delivery.
• Track deliverables, schedules, and scope; review contractor submittals.
• Collaborate with external engineering firms on feasibility and design phases.
• Support CQV activities and site turnover.

Skills

Capital project execution

Project leadership

Risk management

Reading drawings (mechanical/elect/E&I

Education

BS degree in a technical field

Tools

MS Project

Primavera

JIRA

ERP systems (JDE/MD)*(incl. Trackwise/Veeva)

Job description

life insurance, parental leave, paid time off, paid holidays, 401(k)

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.

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 looking for a CAPEX Project Manager that is responsible for the engineering execution and technical oversight of capital projects (expansion and sustainability) within the pharmaceutical manufacturing facility. This role ensures that all projects are delivered safely, on time, within budget, and in compliance with Good Manufacturing Practices (GMP) regulatory requirements and company standards. The position works closely with cross-functional teams including manufacturing, quality, EHSS, maintenance, validation, and procurement to ensure successful project delivery.

The Responsibilities:

• Leads team in defining project strategies, developing goals and ensures project scope, budgets, and schedules are defined to meet project requirements
• Continuously interacts with all functions and levels of management ensuring effective, ongoing communications across teams and stakeholders
• Assists project manager to ensures identification and communication of projects risks, development of risk plan and leads team in the proactive
  management of risk response strategies
• Anticipates potential conflict situations and manages to a successful outcome
• Assists Project Manager to track team deliverables for project completion, to create and maintain project schedules, to control project scope, and to review contractor/engineering firm submittals
• Establish, track and communicate project risks in collaboration with project team
• Participates in all collaborations with external engineering firms in feasibility assessments, concept design, basic design and detail design
• Participates in technical review of all external engineering design reviews
• Develop project URS, RFQs, CCMs, Work Orders, preventative maintenance plans, P&ID redlines, spare parts management among other activities directly
  related to project documentation.
• Collaborates with multifunction teams to develop project Capital Expenditure Requests (CERs) and Front-End Loading (FEL) documents among other documents
  required to obtain project approvals.
• Assists with project CQV (commissioning, qualification, and validation) activities
• Participates in training site stakeholders as project is turned over to the site
• Presents project technical scope to site stakeholders and project sponsors/endorsers
• Participates/leads project technical reviews for assigned projects

Required Qualifications

• BS degree in a technical field or equivalent industry experience (15+ years)
• Experience with capital project execution, from concept to commissioning
• Knowledge of the basic principles in aseptic processing and/or inspection & packaging engineering best practices
• Must be able to lead and execute engineering projects and lead multiple projects simultaneously
• Strong understanding of inspection and packaging materials, processing, and testing methods
• Experience and/or knowledge of PLC, HMI, Vision Systems and Building Management Systems
• Strong oral and written communication skills
• Lean Six Sigma or continuous improvement experience
• Must be able to read mechanical, electrical, and P&ID drawings
• Advanced proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
• Proficient in project management tools (MS Project, Primavera, JIRA, etc.)
• Experience and the ability to use enterprise software (examples include: JDE, Microsoft Dynamics, BPLM, Veeva, Trackwise, etc.)

Physical/safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may also involve walking or standing for long periods of time
• Variable travel of 0-10% could be expected
• Must be able to lift, push, pull, and carry up to 50 lbs
• Must be able to lift 20 lbs overhead
• Must be able to wear personal protective equipment (PPE), as required

In return, you'll be eligible for[1]:

• 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.

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