Senior Project Engineer

Overview

Join a Leader in Pharmaceutical Manufacturing — And Build What’s Next. Jubilant Hollister Stier LLC is a leading force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support life changing medicines around the world. We are recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business leads globally in allergenic extracts that support treatments for allergies and asthma.

Jubilant Hollister Stier is part of the global Jubilant Pharma family.

If you thrive on solving complex problems, improving systems, and building real solutions, you’ll feel at home here. Your ideas matter — and your impact is felt globally.

• Immediate impact:
  Your work directly supports essential medicines and allergenic therapies used worldwide.
• Benefits start on day one:
  Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately.
• A career you can grow:
  Opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity.
• A culture of improvement:
  We value continuous improvement, innovation, and hands-on contribution.
• A stable industry leader:
  Backed by Jubilant Pharma, combining long-term stability with forward-looking innovation.

Senior Project Engineer provides expertise primarily in pharmaceutical facility engineering. This position manages large-scale projects and multi-disciplinary teams, provides technical direction for complex projects, and communicates effectively at all levels. The individual acts as an authority in pharmaceutical engineering and provides leadership and guidance to others.

• Provides expert technical support of engineering facility projects including facility and utility expansion, compliance upgrades, cost reduction, process improvements, and construction projects.
• Designs, optimizes and implements site manufacturing processes to improve efficiency, quality and sustainability.
• Oversees and assesses existing processes and workflows.
• Establishes and tracks process metrics to monitor process stability and identify improvement opportunities.
• Manages comprehensive compliance with cGMP, USP, and global regulatory standards (FDA/EMA) across local and international facility operations.
• Executes end-to-end product life cycle management from initial quotation through product retirement.
• Owns the end-to-end specification process—including URS, FRS, and DDS—and generates technical RFQs for external contractors and OEMs to ensure accuracy in project bidding and delivery.
• Develops and executes validation studies to test and qualify new and improved manufacturing processes.
• Generates reports summarizing study results and uses data to qualify site processes.
• Analyzes cross-departmental data trends to identify and mitigate risks to sterile product integrity.
• Leads the implementation of proactive CAPAs to resolve adverse conditions and ensure continuous compliance.
• Participates in deviation investigations and evaluates impact.
• Oversees technical requirements for cleanroom classifications and aseptic processing, including sterilization, depyrogenation, media fills, and environmental control.

• Bachelor of Science;
  Major:
  Mechanical, Chemical, Bioengineering, or similar engineering discipline required.
• 5-10 years related pharmaceutical experience or FDA-regulated industry experience required.
• Supervisory or other leadership experience required.
• Project management required.
• Statistical analysis preferred.
• Lean Six Sigma preferred.
• Aseptic manufacturing preferred.
• Fill-finish experience preferred.
• Microsoft Office proficiency.
• Strong communication with internal/external customers.
• Strategic leader capable of navigating ambiguity to influence outcomes and drive cross-functional teams without direct authority.
• Experience interacting with inspectors/auditors from regulatory agencies.
• Ability to search for solutions in varying situations.
• Willing to work in classified/aseptic areas and confined spaces; potential exposure to allergens.

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