Job Number: 21319629
- B.A. Or B.S. Degree, preferably in pharmaceutical, biotech, or engineering related field.
- Minimum 8+ years' experience with Qualification/Validation of facilities, utilities, equipment, processes.
- Minimum 2+ years project management experience working in matrix organization.
- Strong working knowledge of GMP and industry regulatory (FDA) requirements.
- Hands-on experience in at least one of the following areas: Cleaning Validation, Process Validation, Quality System Assessments and Implementation, Auditing and Gap/GMP Assessments, Manufacturing Operations in Pharma/Biopharma, Process Engineering or Equipment, Facility and Utility Qualification.
- Strong creative problem solving and analytical skills.
- Software Proficiency MS Office (word, excel, power point), MS Outlook, project management software (MS Project, Primavera, etc.).
- The Validation Manager manages the implementation of global enterprise level validation processes at the site level.
- Additionally, would be responsible and revising local procedures with global procedures and training the site in the new process.
- This highly technical and highly specialized position will be part of the Client global project in streamlining the equipment / utility / facility / computer system qualification process.
- The person will be representing Devens Site and will be a conduit for the qualification feedback for the site and the global group.
- You will organize activities across different groups, ensuring completion of the project within scope and schedule requirements and also help plan and direct new workflow implementation efforts.
- Develop detailed timelines for programs, ensure they are executable and drive execution efforts to deliver on time.
- Manage program risks and ensure that mitigation strategies are in place.
- Manage data review meetings for the programs and ensure key decision points are identified and executed upon.
- Perform gap analysis and kaizen events to bring different project stakeholders' alignment and ensure identification of gaps and driving the risk mitigation arising from them to closure.
- You will report to the Associate Director of Validation Engineering and work to support our scientific strategy by planning activities, tracking activities, and holding stakeholders accountable to project tasks.
- Develop Standard Operating procedures (SOPs) and other governing documents to ensure consistent application of the requirements and strategies.
- Provide technical guidance, establishes project priorities, and schedules activities to ensure timelines and milestones are met.
- Write, review, and approves validation documents to support cleaning validation activities.
- Escalates critical deviations to Quality and Site management's attention.
- Lead cross-functional teams and provides expert guidance to associates to align with the new processes.
- Communicate effectively and promptly at all levels of the organization, supporting department objectives and management decisions.
- Able to lead matrix teams and promote a team approach to identify gaps in the future and current processes and mitigate them.
This 9+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Jim: jim@alphaconsulting.Com
ALPHA'S REQUIREMENT #22-02304
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE