Validation Engineer (Qc Lab)

Validation Engineer (Qc Lab)
Company:

(Confidential)


Place:

Texas


Validation Engineer (Qc Lab)

Details of the offer

The Wooldridge Group is a leading consulting and Professionals services company.

For more than two decades we have partnered with
organizations to address key business needs and identify world:class talent
that is essential their success.

We are currently seeking a Validation Engineer who will support the
Quality Laboratories with the qualification cycle of equipment and computer
systems.

The ideal candidates will be local to commute to the client site and
have 5+ years of Quality Lab experience within a regulated environment (FDA
GMP).

Main Areas of Responsibilities

:

Includes attending status meetings, strategy meetings and other
required meetings as well as maintaining the validation timeline and status for
validation projects.
:

Manages the activities of validation consultants utilized to assist in
the implementations.
:

Develops and communicates project timeline and status.
:

Develops and reviews validation documents and implementation
documentation that supports required validation activities.
:

Documents include Validation Project Plan, Requirements and specifications,
vendor Evaluation Documentation, Installation/Operational/Performance Protocols
and Final Reports.
:

Provides technical assistance, training and work direction to other
staff members.
:

Write protocols that challenge the critical parameters related to
installation, operation, and performance of the related facility, utilities,
computer systems or equipment, and assures that protocols are approved through
proper channels.
:

Executes validation and qualification protocols per related SOPs and
assures that acceptance criterion related to validation and qualification
protocols are met.
:

Interacts with all affected personnel in the execution of protocols and
gathering of test data.
:

Ensures that all test data is gathered and recorded in accordance with
cGMP requirements and industry trends.
:

Carries out responsibilities in accordance with the organizations
policies and procedures, state, federal and local laws.
Requirements

:

Bachelors degree in a science, engineering, or related field from an
accredited college or university, and three (3) to thirteen (13) years
progressively responsible related experience preferably within the food,
cosmetic or pharmaceutical industries.
:

Previous experience with Waters LC equipment and Empower, Mettler
Toledo equipment and LabX, Lonza MODA, and other QC Chemistry and QC
Microbiology equipment is ideal.
:

Current Good Manufacturing Practices (cGMP), Food and Drug
Administration (FDA), United States (USP) and European (EP) Pharmacopeias, and
related federal, state and local laws, codes, regulations and regulatory
requirements.
:

Experience with validating QC Laboratory systems.
:

Pharmaceutical quality control processes.
:

Principles and practices of GAMP 5 qualification and validation.
:

Techniques of sampling, testing and measuring, and principles of
mathematical and statistical computations.
Benefits
The Wooldridge Group is firmly focused on diligently
investing in our employees who enable our company to fulfill our mission and
achieve success by offering a full:suite of affordable benefits.

The Wooldridge Group is an equal opportunity employer. All
aspects of employment including the decision to hire, promote, discipline, or
discharge, will be based on merit, competence, performance, and business needs.
We do not discriminate on the basis of race, color, religion, marital status,
age, national origin, ancestry, physical or mental disability, medical
condition, pregnancy, genetic information, gender, sexual orientation, gender
identity or expression, veteran status, or any other status protected under
federal, state, or local law.


Source: Tiptopjob_Xml


Area:

  • Production - Manufacturing / Quality Assurance

Requirements

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