Validation Engineer I
Location: Saint Louis
Posted on: April 17, 2019
A career at MilliporeSigma is an ongoing journey of discovery: our
51,000 people are shaping how the world lives, works and plays
through next generation advancements in healthcare, life science
and performance materials. For more than 350 years and across the
world we have passionately pursued our curiosity to find novel and
vibrant ways of enhancing the lives of others.
Validation engineers are recognized as a strong quality presence
and technical resource. This position is responsible for
developing, reviewing, and managing the execution of validation
activities, and ensuring that the qualifications are consistent
with user s/manufacturer s requirements and quality standards.
In the role of Validation Engineer, you will also be interacting
cross-functionally with Manufacturing, Project Management, Process
& Analytical Development, Quality Control, Quality Assurance,
Packaging, Materials Management, Engineering, and Maintenance.
* Create and execute protocols for equipment, analytical
instrumentation, cleaning, process controls, and facility
(including but not limited to FAT/SAT/IOQ and PQ documents).
* Utilize GDP in a GMP atmosphere while generating protocols and
* Review and generate closing reports for executed protocols.
* Create validation schedules, coordinate execution efforts with
contractors, production operators, production engineers, customers
and quality assurance staff members.
* Ability to work through a Management of Change system to
determine the impact of proposed changes to the qualification
status of equipment, software, or facilities.
* Sound understanding of Quality Risk Management concepts.
* Specific Responsibilities to include:
* Equipment and Facility Validation:
* Develop/Establish an overall plan for qualifying new equipment or
new/upgraded facility and establishing the proper controls for the
introduction of equipment/facility and/or changes under proper
quality standards (e.g. FDA, EU, ISO, ISPE, etc.)
* Identify and establish revalidation requirements.
* Write and execute qualification packages, technical reports, and
validation master plans
* Physical Requirements (PPE, lifting): This position may require
rare lifting of no more than 35lbs.
* Bachelor s degree in an Engineering or Life Sciences
* 2+ years quality or quality support experience in a cGMP
* Working with current regulatory guidelines and standards
* Working with pharmaceutical standards, rules and guidance (e.g.
FDA, EU, ISO, ISPE, etc.)
* 2+ years facility, equipment, and/or cleaning validation
experience in a cGMP manufacturing setting
* Ability to utilize GDP during document creation and review
* Comfortable in a fast-paced environment with the ability to
adjust to changing priorities
* Flexible and accountable
What we offer: At MilliporeSigma, there are always opportunities to
break new ground. We empower you to fulfil your ambitions, and our
diverse businesses offer various career moves to seek new horizons.
We trust you with responsibility early on and support you to draw
your own career map that is responsive to your aspirations and
priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at
The Company is an Equal Employment Opportunity employer. No
employee or applicant for employment will be discriminated against
on the basis of race, color, religion, age, sex, sexual
orientation, national origin, ancestry, disability, military or
veteran status, genetic information, gender identity, transgender
status, marital status, or any other classification protected by
applicable federal, state, or local law. This policy of Equal
Employment Opportunity applies to all policies and programs
relating to recruitment and hiring, promotion, compensation,
benefits, discipline, termination, and all other terms and
conditions of employment. Any applicant or employee who believes
they have been discriminated against by the Company or anyone
acting on behalf of the Company must report any concerns to their
Human Resources Business Partner, Legal, or Compliance immediately.
The Company will not retaliate against any individual because they
made a good faith report of discrimination.
Keywords: MilliporeSigma, St. Louis , Validation Engineer I, Engineering , Saint Louis, Missouri
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