Job Overview
We are seeking an experienced professional with a background in managing external vendors for pharmaceutical projects and technical expertise in process engineering within biologics manufacturing facilities.
Key Responsibilities:
* Serve as the primary point of contact for all process packages, ensuring alignment with operational requirements.
* Manage project resources, timelines, and budgets to ensure successful and on-time project delivery.
* Lead Quality Event (Deviation) process and Change Control for Process Engineering.
* Support CAPEX projects, including timely implementation and closure.
* Collaborate with cross-functional teams and global engineering functions to drive process improvements and standardization.
* Evaluate equipment capability, fit-for-purpose, and adherence to business needs.
* Provide training to end-users on technical aspects of installed plant assets and support the evaluation and implementation of new technology for process execution and analysis.
Required Qualifications and Skills:
* Proven experience managing external vendors for planning, design, and construction of pharmaceutical projects.
* Previous involvement in Pharmaceutical NPI/Tech Transfer/GreenField projects.
* Proficiency in Functional Specification Management and familiarity with change control processes and systems.
* Knowledge of process safety assessments, hazard identification tools, and process FMEAs.
* Understanding of pharmaceutical industry standards and regulations, particularly FDA regulations.
* Specific experience in biologics manufacturing processes and systems, with familiarity with GMP and other quality standards.
* Strong project management and organizational skills, with the ability to manage multiple tasks simultaneously.
* Excellent communication and interpersonal skills, with the ability to collaborate effectively with diverse teams.