Change Control Expertise
We're seeking an experienced professional to fill an exciting opportunity within a pharmaceutical organization.
* Provide technical support for vaccine drug substance and/or drug product processes to ensure smooth operation, including person-in-plant support directly within the manufacturing facility.
* Support water runs, equipment shakedown runs, engineering runs, and process performance qualification (PPQ).
* Collaborate across multiple technical functions within the organization and the manufacturing team to guarantee successful commercial production.
Responsibilities and Expectations
Author comprehensive change control documentation, technical communications, and process risk management plans.
* Offer technical oversight, management, and planning support for complex partnership models.
* Assess the viability of technology in proposed process configurations and verify adherence to required standards.
* Ensure deliverables meet technical specifications.
* Lead teams for partner risk identification, assessment, and mitigation planning.
* Provide manufacturing process guidance to external partners to resolve production issues and optimize process and capacity efficiency.
* Coordinate investigations with relevant stakeholders from impacted manufacturing sites.
Requirements and Qualifications
Required qualifications include a bachelor's degree in engineering or a related science field. Advanced degrees in engineering, science, or business are preferred.
* Experience in pharmaceutical manufacturing, engineering, and/or technical operations support is mandatory.