Director CAPEX Project Expansion

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:

The Director CAPEX Project Expansions reports to the Head of Engineering and is responsible for leading cross-functional initiatives and project teams for identified large expansion projects. The Director CAPEX Project Expansions will collaborate with VP of Engineering to define project scopes and milestones to achieve commitments and identify issues and risks associated with existing facility assets or new assets. The Director CAPEX Project Expansions is expected to have independent interactions, influence and lead the project team to ensure the accountability for deliverables and commitments and must effectively communicate with support functions, multiple levels of management and customers. They are responsible for ensuring that projects are completed within scope, on time and withing budget.

The responsibilities:

• Influences business decisions, specifically supports the development/sustainability of the site's 10-year CAPEX plan
• Creates financial tracking system and manages actual + forecast spend for expansion projects
• Leads team in defining project strategies, developing goals and ensuring project scope is defined to meet requirements (concept, basic and detail designs)
• Continuous interaction with all functions and levels of management ensuring effective, ongoing communications across teams and stakeholders
• Identifies and communicates 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
• Tracks team deliverables for project completion
• Is responsible for controlling project scope creep and project changes with assistance of project controller
• Participates/leads project technical reviews for all projects
• 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.
• Responsible for training site stakeholders as project is turned over to the site
• Develop Project Management standards used across multiple sites
• Collaborates and supports projects across sites (Bloomington, IN and Halle, Germany)
• Formal and Informal mentorship
• Responsible for scheduling and leading project kick-off meeting, weekly/monthly team meetings
• Oversee construction/installation activities and responsible for contractor daily work permits/JSA

Required qualifications:

• Bachelor's degree in engineering or equivalent is required.
• Minimum 10 years' experience in pharmaceutical engineering and/or project management experience.
• Prior experience working in aseptic manufacturing plant.

• Must have a working knowledge of project management tools and possess knowledge of related disciplines. PMP (Project Management Professional) Certification is preferred.

Additional requirement(s):

• Proven Leadership skills, with the ability to motivate and manage a diverse team (internal & external).
• Must possess strong ability to negotiate and maximize effectiveness of resources and influence others internally and externally to meet business objectives
• Excellent communication skills and the ability to collaborate effectively with various stakeholders.
• Risk Management knowledge is required

• Must have knowledge of GMPs and worldwide regulatory agency guidelines
• Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events to drive positive changes on the floor, and a solid understanding of DMAIC.)
• Computer proficiency in Microsoft Word, Power Point, MS Projects, Excel, and Outlook and the ability to use enterprise software

Physical / Safety Requirements:

• Ability to stand or sit for extended periods of time
• Duties may require overtime work, including nights and weekends
• Must be able to gown qualify for Grade A/B areas

In return, you'll be eligible for:

• 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
• Employee Ownership Plan




• 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

Current benefit offerings are in effect through 12/31/25

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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