No more applications are being accepted for this job

Validation Engineer - Saint Louis, United States - Entegee

Entegee Saint Louis, United States

1 month ago

Description

Job Description

Job Summary:
The Validation Engineer supports cleanroom and analytical instrument qualifications and computerized system validations within a pharmaceutical manufacturing framework following cGMP standards.

Job Requirements:

Experience with URS, vendor qualifications, IQ/OQ documentation, and PQ protocols for analytical instrument and computerized systems.
Engineering or Science degree with a minimum of 5 years of validation engineering experience.
Experience with chillers and freezers highly preferred.
Familiarity with pharmaceutical standards and regulations (FDA, EU, ISO, ISPE, etc.).
Additional experience in validation of analytical equipment, associated software, and temperature units.
Proficient in using Good Documentation Practices (GDP) during document creation and review.
Ability to thrive in a fast-paced environment and manage shifting priorities.

Preferred Skills:

Ability to create and manage validation schedules and coordinate execution with various teams.
Proficient in generating protocols, reviewing documents, and generating reports in a GMP atmosphere.
Knowledge of Quality Risk Management principles.
Proficient in managing changes to ensure continued qualification of systems, equipment, and facilities.

Job Responsibilities:

Support the qualification of cleanrooms, analytical instruments, and computerized systems.
Collaborate with Engineering, Maintenance, Manufacturing, QA, IT, and other departments during protocol execution.
Develop and review URS, vendor qualifications, IQ/OQ documentation, and PQ protocols for analytical instrument/computerized systems.
Analyze engineering study results to formulate conclusions and recommendations.
Author and review design documents for analytical instruments/computerized systems.
Assess impacts of proposed changes on validated states of instruments and systems.
Execute qualification protocols for equipment, instrumentation, and facilities.
Generate closing reports for executed protocols and manage validation schedules.
Navigate a Management of Change system to assess and manage changes impacting qualification status.
Focus on Controlled Temperature Unit qualifications, with secondary priority on Analytical Instrument qualifications.
Conduct annual validation reviews to ensure compliance and identify areas needing attention.

Pay Details: $54.00 to $72.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.Company DescriptionSpecializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. My client will expand anyone resume and build them to be a top performing controls engineer.

Company Description

Specializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. My client will expand anyone resume and build them to be a top performing controls engineer.

Validation Engineer III

1 week ago

Kindeva Drug Delivery St Louis, United States

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we w ...
Validation Engineer

2 weeks ago

Omega Enterprises Smithton, United States

Mi-Jack Europe GmbH is a leading company in port automation and security. To support our dynamic team, we are currently looking for a Validation Engineer. Your role is crucial for the development, implementation, and monitoring of our quality assurance processes, as well as for t ...
Validation Engineer III VIII

1 week ago

Kindeva Drug Delivery St Louis, United States

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we w ...
Validation Engineer

3 weeks ago

Ingenics Corporation USA Chesterfield, United States

Validation Engineer · Establish performance and quality criteria · Create and run quality tests based on appropriate protocols · Perform production process validations · Evaluate engineering systems and processes · Calibrate and repair systems and machinery · Prepare and maintain ...
Verification and Validation Engineer

3 weeks ago

bioMerieux Inc. Hazelwood, United States

Verification and Validation Engineer · Location: Hazelwood, MO, United States · Position Type: Unfixed Term · Job Function: Engineering · Share: · share to e-mail · Apply Now > · A family-owned company, bioMerieux has grown to become a world leader in the field of in vitro diagno ...
Verification and Validation Engineer

2 weeks ago

BioFire Diagnostics Hazelwood, United States

Benefits at bioMrieux: · + Low-cost medical, dental, and vision benefits starting day one · + 11 paid holidays · + 160 hours of paid time off · + Annual bonus · + 9.5% 401k company contribution with no vesting period · + Tuition reimbursement up to $10000 per calendar year ...
Test engineer

2 weeks ago

Apex Ventures Mound City, United States

Schmitt Engineering is a medium-sized company headquartered in Erlangen, Germany. With many years of engineering expertise in various industries, we are a trusted partner of the industry. Our activities cover the entire process chain, from planning and project management to devel ...
Engineer in building services as an expert for the inspection of building technical systems, if necessary for training"

2 weeks ago

Phoenix Ventures St. Louis, United States

Job Description As an experienced expert, you will support our sales representatives in the St. Louis area in expanding and developing the market in close cooperation. You will be the competent contact person for our customers for long-term collaboration. Your responsibilities wi ...
Automation Engineer

1 week ago

MyKelly St. Louis, United States Full time

Automation Engineer · This position provides manufacturing engineering support to a Medical Device and Disposables manufacturing operation. · Primary responsibilities include support of existing and new automation initiatives in the Disposable Packs Value Stream. · Specification, ...
Process Engineer

1 day ago

STERIS St. Louis, United States

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. · Position Summary · Responsible for establishing manufacturing process capability for new/reformulated product ...
Hardware Engineer III

2 days ago

Nidec Motor Corporation St. Louis, United States Full time

Job Summary · The Hardware Electronics Engineer III develops and designs motor control power electronics through the product development lifecycle. Work within a team, from customers, suppliers and manufacturers, to translate designs into production. Provide technical guidance to ...
Sr. Process Engineer

1 hour ago

Thermo Fisher Scientific St. Louis, United States Full time

: mplement process improvements to optimize efficiency and productivity in the upstream manufacturing processes · Collaborate with teams from different departments to ensure smooth execution of process development and technology transfer activities. · Lead and support process ...
Postdoctoral Researcher

1 week ago

Washington University in St. Louis St. Louis, United States

We are a protein design and engineering lab combining state-of-the-art technologies in computational protein design with experimental validation. This is a unique moment as protein design using AI is rapidly becoming very successful in generating custom proteins. We are developin ...
Electrical Engineer III

5 days ago

Salas O'Brien St. Louis, United States

Job Summary: · The Electrical Engineer II/III provides expertise and support in a variety of areas including electrical, instrumentation, and controls design, deliverables development, using data from other disciplines to prepare engineering designs, and directing engineers and d ...
Senior Mechanical Engineer, PE

1 week ago

VetStaff, LLC St. Louis, United States

Job Description · Senior Mechanical Engineer Primary Responsibilities: · Sizing and preparation of specifications for mechanical equipment and systems. · Design for materials handling, conveyor systems, crushing and screening system, dust collection, control systems, chute, duct, ...
Mechanical Engineer III

1 week ago

Salas O'Brien St. Louis, United States

Job Summary: · The Mechanical Engineer III provides expertise and support in a variety of areas including resource management, preparation, and oversight of mechanical designs, providing extensive knowledge in ASME, CEMA, and Industrial Ventilation Guidelines, and preparation of ...
Structural Analysis Engineer 4

1 week ago

The Fountain Group St Louis, United States

Leads development, integration and documentation of structural requirements to establish the system design. Coordinates with other engineering groups to establish the product's environment. Guides product design and verifies structural integrity by using and developing analytical ...
QC Construction Inspector

2 weeks ago

Terracon St. Louis, United States Regular, Full time

· Job Description · Do you want to supercharge your career? Would you like to be part of constructing a signature transportation project? Then you are in luck. · Terracon is providing QA and QC inspection and testing services on the Chester Bridge. The Chester Bridge will be a n ...
VP, Software

3 weeks ago

Zelis St. Louis, United States Full time

POSITION OVERVIEW · The Zelis Data Intelligence team seeks a visionary, engaging, and results-oriented leader who seeks a role supporting a rapid growth tech-enabled healthcare company. The VP, Engineering will lead scaling the global data and software engineering teams in manag ...
Engineering Design Manager

6 days ago

Alberici Constructors St. Louis, United States Full time

Headquartered in St. Louis, Missouri with more than 1,200 employees and $1.5B in revenue, Alberici is a diversified construction company that partners with leading organizations throughout North America to build their most challenging and important projects. · Since our founding ...