Validation Engineer
Aequor JD ·www.aequor.com
Apply directVALIDATION ENGINEER 1
Summary: Under general supervision, reviews specifications and determines the critical aspects
of facilities, utilities, computer systems and manufacturing equipment with regard to product and
process quality, writes qualification protocols for operating systems and records related test
results; prepares final reports that identify the results of protocol testing and the conditions of
release.
Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a
representative summary of the major duties and responsibilities. Incumbent(s) may not be
required to perform all duties listed, and may be required to perform additional, position-specific
tasks.
• Carries out responsibilities in accordance with the organization's policies, procedures,
and state, federal and local laws.
• Reviews electrical, mechanical, and software/computer specifications in manufacturer
and blue print form, and identifies critical parameters.
• Writes protocols that challenge the critical parameters related to installation, operation,
and performance of the related facility, utilities, computer systems, or equipment.
• Assures that protocols are approved through proper channels; writes and revises
validation protocols.
• Executes validation and qualification protocols per related SOPs and assures that
acceptance criterion related to validation and qualification protocols are met.
• Assures that all test data is gathered and recorded in accordance with cGMP
requirements.
• Analyzes data to ascertain if it meets related protocol acceptance criteria; writes deviation
reports as required upon failures to meet protocol acceptance criteria.
• Writes final reports and assures that they are approved through proper channels.
• Develops and communicates project timelines and status.
• Complies with all GMP and safety requirements, SOP's and Company policies and
procedures.
Performs equipment and system qualification periodic reviews.
• Performs related duties as assigned.
Required Knowledge and Skills :
Knowledge of :
• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA),
and other regulatory requirements.
• Pharmaceutical principles, practices and applications.
• English usage, spelling, grammar and punctuation.
• Principles of mathematical and statistical computations.
• Personal computer operations and Microsoft applications (Word, Access, and Excel).
Skill in:
• Interpreting software and ladder logic diagrams and flowcharts.
• Interpreting electrical, and mechanical blue prints and specifications including HVAC
systems and. construction plans.
• Solving practical problems and considering a variety of concrete variables in situations
where only limited standardization exists.
• Communicating clearly and concisely, both orally and in writing.
• Establishing and maintaining good relationships with those encountered in the course of
work.
• Operating a personal computer.
Physical Requirements and Working Conditions : Incumbents in this class are subject to
extended periods of sitting, standing, walking, pushing and pulling, stooping and crouching
climbing and walking, vision to monitor, occasional lifting of equipment or materials weighing up
to 25 pounds. Incumbents may be exposed to toxic materials, toxic gases, electrical hazards, and
dangerous tools and equipment. Work is performed in a manufacturing environment.
Minimum Qualifications: Bachelor's degree in Engineering or a related field from an accredited
college or university and zero (0) to one (1) year of engineering validation experience, preferably
in a pharmaceutical environment, or an equivalent combination of training and experience.
Summary: Under general supervision, reviews specifications and determines the critical aspects
of facilities, utilities, computer systems and manufacturing equipment with regard to product and
process quality, writes qualification protocols for operating systems and records related test
results; prepares final reports that identify the results of protocol testing and the conditions of
release.
Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a
representative summary of the major duties and responsibilities. Incumbent(s) may not be
required to perform all duties listed, and may be required to perform additional, position-specific
tasks.
• Carries out responsibilities in accordance with the organization's policies, procedures,
and state, federal and local laws.
• Reviews electrical, mechanical, and software/computer specifications in manufacturer
and blue print form, and identifies critical parameters.
• Writes protocols that challenge the critical parameters related to installation, operation,
and performance of the related facility, utilities, computer systems, or equipment.
• Assures that protocols are approved through proper channels; writes and revises
validation protocols.
• Executes validation and qualification protocols per related SOPs and assures that
acceptance criterion related to validation and qualification protocols are met.
• Assures that all test data is gathered and recorded in accordance with cGMP
requirements.
• Analyzes data to ascertain if it meets related protocol acceptance criteria; writes deviation
reports as required upon failures to meet protocol acceptance criteria.
• Writes final reports and assures that they are approved through proper channels.
• Develops and communicates project timelines and status.
• Complies with all GMP and safety requirements, SOP's and Company policies and
procedures.
Performs equipment and system qualification periodic reviews.
• Performs related duties as assigned.
Required Knowledge and Skills :
Knowledge of :
• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA),
and other regulatory requirements.
• Pharmaceutical principles, practices and applications.
• English usage, spelling, grammar and punctuation.
• Principles of mathematical and statistical computations.
• Personal computer operations and Microsoft applications (Word, Access, and Excel).
Skill in:
• Interpreting software and ladder logic diagrams and flowcharts.
• Interpreting electrical, and mechanical blue prints and specifications including HVAC
systems and. construction plans.
• Solving practical problems and considering a variety of concrete variables in situations
where only limited standardization exists.
• Communicating clearly and concisely, both orally and in writing.
• Establishing and maintaining good relationships with those encountered in the course of
work.
• Operating a personal computer.
Physical Requirements and Working Conditions : Incumbents in this class are subject to
extended periods of sitting, standing, walking, pushing and pulling, stooping and crouching
climbing and walking, vision to monitor, occasional lifting of equipment or materials weighing up
to 25 pounds. Incumbents may be exposed to toxic materials, toxic gases, electrical hazards, and
dangerous tools and equipment. Work is performed in a manufacturing environment.
Minimum Qualifications: Bachelor's degree in Engineering or a related field from an accredited
college or university and zero (0) to one (1) year of engineering validation experience, preferably
in a pharmaceutical environment, or an equivalent combination of training and experience.
Frequently asked questions
Who is hiring for the Validation Engineer role?
Aequor JD is hiring for the Validation Engineer position, a Shazamme client. Apply directly on the employer's career site.
Where is the Validation Engineer job located?
The Validation Engineer role with Aequor JD is based in Davie, FL, US.
What does the Validation Engineer role pay?
Aequor JD lists the Validation Engineer role at USD 40–45 per hour.
Is the Validation Engineer role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the Validation Engineer role?
The Validation Engineer position is aimed at mid-level candidates.
How do I apply for the Validation Engineer role at Aequor JD?
Apply directly on Aequor JD's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.