R&D Document Control & Data Specialist

World Vision International (New); León; Vor Ort; EUR 134.000 - 170.000; Vollzeit

Zusammenfassung

PCI Pharma Services is seeking a Principal Engineer to provide SME leadership in isolated sterile fill finishing and lyophilization. You will oversee Front End Engineering Design, drive project scope definitions, and coordinate external partners with internal teams to meet business objectives.

The role requires PMP or equivalent accreditation, a strong background in cGMP environments, and experience shaping engineering standards with a Lean approach. Based in a dynamic biopharma setting.

Qualifikationen

• BS in Chemical, Mechanical, or other Engineering degree is required.
• Project Management Professional (PMP) certification or similar accreditation is required.
• Masters degree in Engineering is preferred.

Aufgaben

• Be SME in isolated or RABS sterile fill finishing and lyophilization equipment.
• Manage Front End Engineering Design efforts to develop project scopes and budgets.
• Lead and coordinate external engineering partners and internal cross functional teams.
• Develop and implement segment level engineering standards, governance, and lean practices.

Kenntnisse

Aseptic processing

Leadership

Project management

Quality systems familiarity

Ausbildung

BS in Chemical, Mechanical, or other Engineering

Masters degree in Engineering (preferred)

Tools

PMP certification

Jobbeschreibung

PCI Pharma Services is seeking a Principal Engineer to provide SME leadership in isolated sterile fill finishing and lyophilization. You will oversee Front End Engineering Design, drive project scope definitions, and coordinate external partners with internal teams to meet business objectives.

The role requires PMP or equivalent accreditation, a strong background in cGMP environments, and experience shaping engineering standards with a Lean approach. Based in a dynamic biopharma setting.