Head of Project Management

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 RIGHT - We hold ourselves to a high standard of excellence,fulfilling our commitments to the customer, their patients, and our team members.

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.

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

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

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

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.)

Duties may require overtime work, including nights and weekends

Variable travel of 0-10% could be expected

Must be able to wear personal protective equipment (PPE), as required

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

Paid Holidays

Adoption Reimbursement Program

Employee Assistance Program

Community and Volunteer Service Program

Short and Long-Term Disability Insurance

Legal and more

Workout Facility

Credit Union

[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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