Senior Process Engineer - Cleaning Validation

(Job Id W280743)
Posted on 3/6/2010
Location:

United States


Job Type:

Full Time


Salary: $90000.00 to $125000.00/year
Degree: Master
Job Description
VALIDATION HOT BUTTONS:
CLEANING VALIDATION MASTER PLANNING
CYCLE DEVELOPMENT
PROGRAM MANAGEMENT

Our client has a need within their Sterile Validation group for Senior Process Engineer (biological company). Responsibilities include providing documented evidence that processes are consistent and reliable through challenges against pre-established criteria for all vaccines (worldwide) and sterile pharmaceuticals. The Senior Process Engineer will support cleaning validation.
Responsibilities include but are not limited to:
o In-depth technical support for cleaning validation activities, including investigations, protocol development, maintaining regulatory compliance of procedures, and maintaining training materials.
o In-depth experience with cleaning concepts, cleaning system design, operation and validation, and regulatory requirements for pharmaceutical systems.
o Support the cleaning validation systems to ensure compliance with current industry and regulatory trends.
Educational requirement:
o BA/BS Degree in engineering, biology, or relevant science discipline.

Responsibilities are as follows:
o Process Validation activities and principles for Vaccine manufacturing.
o Validation oversight of new product introductions.
o Validation oversight of new facility projects.
o The individual will serve as a Subject Matter Expert for Process Validation. This will include the development of standards, requirements, tools and templates.
o Knowledge of industry and regulatory trends.
o Provide leadership and initiative assuring company practices maintain a standard of best practice.
o Manage a group of initially between 3 and 8 individuals who will have direct responsibility for the management of process validation activities across product lifecycles, from development through routine operations.
Educational Requirements
o BS, MS or PhD in Chemical Engineering, Biochemistry or comparable scientific field.
Required
o Minimum 3 years direct responsibility for Process Validation of Biologics and minimum 5 years experience with biological manufacturing processes.
Desired
o PhD preferred.
o Experience with aseptic operations


Required:
o In-depth knowledge of GMPs, and Validation.
o Excellent teamwork and leadership skills.
o Strong quality orientation, good work ethics, and multi-tasking capability.
o Possess the following attributes: analytical, creative, and innovative.
o Five years in a technical or validation position within the pharmaceutical industry.
o Experienced in cleaning system design, operation, and/or validation.
o Experienced in pharmaceutical regulations.
o Strong technical analysis, acumen, and problem solving skills.
o Strong oral and written communication.
o Independent handling of complex projects.
Desired
o Prefer an advanced Degree
o Experience in pharmaceutical regulatory inspections.
o Publications or presentations on cleaning validation, design and/or operation.
o 5 years in a validation or technical position supporting cleaning systems.