Validation Engineer III

Purpose: SUMMARY The Validation Engineer III position is a senior level position in the Validation Department with the primary responsibilities of independently leading Validation and Qualification projects for the completion of Process Validations, Cleaning Validations, IQ, OQ, PQ qualifications, Commissioning plans, Technology Transfers and Submission Batches

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Leads a project team for the development of Process Validation protocols, Cleaning Validation protocols, IQ protocols, OQ protocols, PQ protocols and Commissioning plans
- Leads a project team for the execution of approved Process Validation protocols with the support of Operations personnel
- Leads a project team for the execution of approved IQ, OQ and PQ qualification protocols and directs contractors to support protocol execution
- Leads a project team for the execution of approved Technology Transfer and Submission Batch protocols
- Reconciles Process Validation data including In-process Manufacturing testing, In-process QC testing and Finished Product QC testing for the preparation of reports
- Reconciles Cleaning Validation data including equipment residue QC testing for the preparation of reports
- Reconciles IQ, OQ, PQ and Commissioning data including testing and monitoring results for the preparation of reports
- Reconciles Technology Transfer and Submission Batch data
- Sources Vendors and Contractors to support Validation department projects
- Leads Factory Acceptance Test (FAT) teams at Vendor sites
- Writes project status reports for communication with the Validation Manager
- Prepares project schedules in MS Project
- Writes other reports and correspondence as required.
- Reviews, amends, and writes applicable SOP?s.
- Assures cGMP and SOP compliance.
- Participant of the Lock Out, Tag Out program and other safety programs.
- Leads internal audit teams and cross-functional teams as required

SUPERVISORY RESPONSIBILITIES
Leads project team members for the completion of project related activities

QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Expert with current Good Manufacturing Practices (cGMP?s)
- Expert with pharmaceutical manufacturing equipment and facilities

EDUCATION and/or EXPERIENCE
Bachelor Degree in Engineering (preferably majoring in Chemical or Mechanical) with a minimum of ten (10) years of related pharmaceutical validation experience or Bachelor Degree in the Sciences with a minimum of twelve (12) years of related pharmaceutical validation experience or a minimum of fifteen (15) years of related pharmaceutical validation experience

Classification:
Direct Placement

Compensation:
Negotiable Year

Join Aerotek CESM, one of the leading providers of engineering and engineering support professionals in North America. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across a number of different industries. We know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek CE offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek CE team! Allegis Group and its subsidiaries is an equal opportunity employer.

Required Qualifications:
Skills Requirements:
IQ, OQ, PQContact Information
Contact:Falconieri,Lee D