Senior Project Manager, Capital Projects

INCOG BioPharma; Fishers (IN); On-site; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a dynamic leader for large capital project investments. This role involves managing complex projects, ensuring compliance with GXP manufacturing standards, and collaborating with various stakeholders to deliver unified engineering solutions. The ideal candidate will have a strong background in engineering, project management, and a passion for driving project excellence. Join a forward-thinking company where your expertise will contribute to innovative advancements in the pharmaceutical sector, and help shape the future of biopharmaceutical engineering.

Qualifications

• 8+ years of experience in project management and engineering support.
• Expertise in GXP manufacturing and regulatory requirements.

Responsibilities

• Lead cross-functional teams on complex capital projects.
• Develop project documentation and ensure compliance.

Skills

Project Management

Engineering Support

Cross-functional Team Leadership

Risk Assessment

Process Improvement

Education

Bachelor's degree in Engineering

Bachelor's degree in Biochemical Engineering

Bachelor's degree in Biotechnology

Bachelor's degree in Life Sciences

Tools

Project Management Tools

GXP Manufacturing Standards

Regulatory Compliance Tools

Job description

This position will serve as INCOG’s leader for large capital project investment including project management and engineering support for projects. The position is responsible for supporting design, construction, CQV and start-up activities. The leader will seamlessly work with A&E, General Contractors, OEMs, and Suppliers to provide unified engineering solutions. Additionally, author project documents, equipment impact assessments, root-cause analysis reports, technical reports, and provide technical assessments, rationales and approval for engineering and changes as well as documentation pertaining to process utilities and equipment to meet regulatory requirements.

Essential Job Functions:

1. Lead cross-functional project teams executing a portfolio of complex, large capital projects.
2. Independently identify, understand, and leverage project stakeholder requirements, expectations, and needs.
3. Develop a collaborative work environment with a cross-functional internal and external team.
4. Drive project management excellence.
5. Prioritize multiple tasks to achieve project timelines, scope and budget.
6. Coach/mentor project workstream leads through the project's lifecycle.
7. Identify best practices to improve existing or develop new improved processes.
8. Monitor and analyze project performance to maintain Key Project Indicators.
9. Ensure successful project execution by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and start-up issues.
10. Work closely with design teams to assure equipment and process reliability.
11. Work with vendors and suppliers to define requirements and understand functional specifications.
12. Develop project and technical documentation (RFPs, equipment specifications, schedules, project reports, etc.).
13. Work flexible hours for the coverage of project demand.
14. Other duties as assigned.

Special Job Requirements:

1. Practical expertise with GXP manufacturing, Plant/Clean utilities, and regulatory requirements for pharmaceuticals and EHS&S bodies.
2. Established track record managing multiple strategic projects.
3. Demonstrated knowledge of project management and project controls tools.
4. Bachelor’s degree in engineering field, biochemical engineering, biotechnology, or life sciences
5. 8+ years of relevant work experience

Additional Preferences:

1. PE or PMP certification.