Validation Engineer I

Purpose: SUMMARY The Validation Engineer I position is an entry level position in the Validation Department with the primary responsibilities of assisting with the development and execution of Process Validation protocols, Cleaning Validation protocols, IQ protocols, OQ protocols, PQ protocols, Commissioning plans, Technology Transfer protocols and Submission Batch protocols under the direction of the Validation Manager

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Assists with the development of Process Validation protocols, Cleaning Validation protocols, IQ protocols, OQ protocols, PQ protocols and Commissioning plans under the direction of the Validation Manager
- Executes approved Process Validation protocols with the support of Operations personnel under the direction of the Validation Manager
- Executes approved IQ, OQ and PQ qualification protocols and directs contractors to support protocol execution under the direction of the Validation Manager
- Executes approved Technology Transfer and Submission Batch protocols under the direction of the Validation Manager
- Collects, summarizes and analyzes Process Validation data including In-process Manufacturing testing, In-process QC testing and Finished Product QC testing for the preparation of reports
- Collects, summarizes and analyzes Cleaning Validation data including equipment residue QC testing for the preparation of reports
- Collects, summarizes and analyzes IQ, OQ, PQ and Commissioning data including testing and monitoring results for the preparation of reports
-Collects, summarizes and analyzes Technology Transfer and Submission Batch data
- Assists with Factory Acceptance Test (FAT) teams at Vendor sites
-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.
- Participates as a team member with internal audit teams and cross-functional teams as required

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.
- Knowledge of current Good Manufacturing Practices (cGMP?s)
- Able to complete Algebraic, Geometric and Statistical calculations for data analysis
- Able to use MS Word, MS Excel and MS Outlook for report preparation, data analysis and interoffice communication


EDUCATION and/or EXPERIENCE

Bachelor Degree in Engineering ( preferably majoring in Chemical or Mechanical) or Bachelor Degree in the Sciences with a minimum of two(2) years of related pharmaceutical manufacturing experience or a minimum of five (5) 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