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Contract Cleaning Validation Engineer Jobs in Texas

Mativ

Validation Engineer

Dallas, TX · On-site

Validation Engineer Mativ is a global leader in specialty materials headquartered in Alpharetta ... Experience with validation of cleaning, software, automated systems, packaging and laboratory ...

Fujifilm

Sr. Validation Engineer

College Station, TX · On-site

Position Overview Sr. Validation Engineer for FUJIFILM Diosynth Biotechnologies Texas, LLC, located ... FUSE Systems, including Classified Clean Rooms, Clean Utilities, Sterilization Equipment ...

Immatics NV

Validation Engineer II

Houston, TX · On-site

The Validation Engineer II will build and execute a periodic review program for our validated ... Draft SOPs and work instructions for system operation, maintenance, and cleaning. * Assist in ...

Immatics NV

Validation Engineer II

Houston, TX · On-site

The Validation Engineer II will build and execute a periodic review program for our validated ... Draft SOPs and work instructions for system operation, maintenance, and cleaning. * Assist in ...

Empower Pharmacy

Validation Engineer II

Houston, TX · On-site

Supports qualification and operation of sterilization, cleaning, lyophilization, and manufacturing systems supporting production readiness and validation requirements. Utilizes AI-enabled monitoring ...

Graphcore

Staff Hardware Validation Engineer

Austin, TX · Hybrid

This role is responsible for defining validation strategies, developing test plans, executing hands ... Experience working with ODMs, contract manufacturers, or external engineering partners. * Strong ...

krg technology inc

CPU Validation Engineers

Austin, TX · On-site

Contract Job Responsibilities Include: Write verification test plans, and associated tests to ... Validation Engineers can anticipate failure modes, and write punishing test content to stress the ...

Graphcore

Staff Hardware Validation Engineer

Austin, TX · On-site

This role is responsible for defining validation strategies, developing test plans, executing hands ... Experience working with ODMs, contract manufacturers, or external engineering partners. * Strong ...

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Contract Cleaning Validation Engineer information

What is a contract cleaning validation engineer?

Contract Cleaning Validation Engineers are professionals who specialize in ensuring that cleaning procedures in manufacturing environments, especially in industries like pharmaceuticals and biotechnology, meet regulatory and quality standards. They are typically hired on a contract basis to validate and document that cleaning processes effectively remove contaminants and residues from equipment and facilities. Their work includes developing and executing cleaning validation protocols, analyzing test results, and preparing reports for regulatory compliance. These engineers play a crucial role in maintaining product safety and quality, and their expertise helps companies pass regulatory inspections. Contract Cleaning Validation Engineers often work with cross-functional teams and need strong knowledge of industry guidelines such as those from the FDA and EMA.

What are the key skills and qualifications needed to thrive as a contract cleaning validation engineer?

To thrive as a Contract Cleaning Validation Engineer, you need a strong background in chemical engineering, microbiology, or a related field, along with experience in cleaning validation within regulated industries. Familiarity with validation protocols, regulatory standards (such as FDA or EU GMP), and statistical analysis software is typically required. Attention to detail, problem-solving skills, and effective communication are crucial for documenting processes and collaborating with cross-functional teams. These skills ensure cleaning processes are compliant, reproducible, and safe, which is vital for product quality and regulatory approval.

What are some common challenges faced by a contract cleaning validation engineer during a project?

Contract Cleaning Validation Engineers often encounter challenges such as aligning cleaning protocols with both client requirements and regulatory standards, managing tight project timelines, and navigating complex equipment or facility layouts. Additionally, collaborating effectively with client teams and other contractors is crucial to ensure that validation documentation is accurate and comprehensive. Staying up-to-date with evolving industry regulations and best practices is also essential to delivering successful validation outcomes.

What is the difference between Contract Cleaning Validation Engineer vs Quality Assurance Specialist?

AspectContract Cleaning Validation EngineerQuality Assurance Specialist
CredentialsValidation certifications, engineering backgroundQA certifications, quality management training
Work EnvironmentPharmaceutical, biotech, or cleanroom facilitiesManufacturing, production, or laboratory settings
Employer & IndustryContract-based roles in regulated industriesIn-house or consulting roles in various industries
Search & Comparison IntentFocus on cleaning validation processesFocus on overall quality assurance practices

The Contract Cleaning Validation Engineer primarily specializes in validating cleaning processes within regulated environments like pharmaceuticals and biotech. In contrast, a Quality Assurance Specialist oversees broader quality systems, including audits and compliance. While both roles require understanding of industry standards, the validation engineer focuses on specific cleaning validation tasks, whereas the QA specialist manages overall quality assurance programs.

What are popular job titles related to Contract Cleaning Validation Engineer jobs in Texas?

For Contract Cleaning Validation Engineer jobs in Texas, the most frequently searched job titles are:

What job categories do people searching Contract Cleaning Validation Engineer jobs in Texas look for?

The top searched job categories for Contract Cleaning Validation Engineer jobs in Texas are:

What cities in Texas are hiring for Contract Cleaning Validation Engineer jobs?

Cities in Texas with the most Contract Cleaning Validation Engineer job openings:

Contract Cleaning Validation Engineer jobs near you

Validation Engineer

Mativ

Dallas, TX • On-site

Full-time

Posted 12 days ago

Mativ rating

6.6

Company rating: 6.6 out of 10

Based on 21 frontline employees who took The Breakroom Quiz

Job description

Validation Engineer
Mativ is a global leader in specialty materials headquartered in Alpharetta, Georgia. The Company offers a wide range of critical components and engineered solutions that connect, protect, and purify our world.
Mativ is a global leader in specialty materials headquartered in Alpharetta, Georgia. The Company offers a wide range of critical components and engineered solutions to solve our customers' most complex challenges.
Position Title: Validation Engineer
FLSA: Salary Exempt
Location: Dallas, Texas
Description:
The Validation Engineer is responsible for managing, inspecting, testing, and modifying the instrumentation, equipment, mechanics, and procedures used to manufacture products in accordance with all company Standard Operating Procedures and manufacturing instructions, and to ensure all systems and processes are running correctly and efficiently to produce high quality products. He/she will also be responsible for generating and executing the site validation master plan. This position has no direct reports.
responsibilities:
Performs validation studies on manufacturing equipment, including equipment set up and qualification, manufacturing process validation, as well as cleaning validation, and ensuring systems remain in a qualified, operational state of compliance associated with cGMP manufacturing work environment.
  • Generates, reviews, and executes the master validation plan, validation protocols (IQ, OQ, PQ) on equipment, utilities, and computerized systems ensuring compliance with cGMP.
  • Prepares all implementation of change request using the "Change Management Request" (CMR) process initiated internally or from customers by collecting all relevant documentation, initiating a change request, route for approvals, implement the plan and close the request accordingly.
  • Apply concepts of Continuous Monitoring through Statistical Process Control (SPC) to ensure the processes that have been transferred into production are monitored and controlled appropriately to maintain the equipment in a validated state.
  • Prepares protocols, reports, and other necessary documentation for validation to determine whether systems and processes meet required criteria and specifications; identifies root causes of production or equipment problems
  • Evaluating current equipment and procedures used in production to certify operations are within regulations
  • Investigates and conducts troubleshooting and root cause analysis of validation related incidents and deviations
  • Resolve CAPA's, non-conformances, protocol incidents, and change controls related to validation protocols
  • Generate data and reports for the validation periodic monitoring and re-qualification programs
  • Establish validation standards, develop testing protocols, prepare equipment, document test results and analyze results to ultimately determine if a new process or new equipment meets policies and standards.
  • Communicate with outside vendors to identify new equipment or perform equipment troubleshooting if problems arise.
  • Maintains validation documentation through the validation lifecycle including protocols, , deviations and corrective actions.
  • Perform risk assessments, failure mode effects analysis (FMEA), and statistical data analysis to support validation activities.
  • Represents the engineering process during customer, certification and regulatory audits (internal and external)
  • Assist in investigating deviations related to facilities, utilities, and equipment.
  • Participates in multi-functional department teams for facilities, utilities, and equipment to meet established project timelines; says current with regulatory trends and validation best practices to enhance validation strategies.
  • Write new and revise current Standard Operating Procedures (SOPs) and Work Instructions as needed.
  • Other duties as assigned by management.

qualifications:
Required
  • BS in Engineering (Chemical preferred), life sciences or related field.
  • 3+ years of validation work experience in a pharmaceutical and/or medical device industry.
  • Certified Quality Engineer/Validation professional a plus
  • Experience with validation of cleaning, software, automated systems, packaging and laboratory equipment desired.
  • Experience authoring and executing Validation protocols such as Installation and equipment operation.
  • Strong understanding of FDA regulations, cGMP, ISO 13485, ICH guidelines and risk management principles.
  • Proficiency in validation software, statistical analysis tools, and data integrity principles is a plus.
  • Strong problem-solving skills with the ability to analyze technical issues and propose solutions.
  • Excellent interpersonal, communication and documentation skills.
  • Ability to work independently and in cross-functional teams in a fast-paced environment.

Preferred
  • Must have the ability to work both independently and as a greater team. Must be able to coordinate work with customers, supervisors, and information partners frequently in different states and/or countries.
  • Must be able to work in a fast-paced environment. Must be able to manage multiple projects while minding priorities. Must be able to make informed, strategic decisions, even when under pressure or when working with resource limitations.
  • Must always have a mindset to protect the interests and health of our consumers, our company, and our customers.
  • Must work well cross-functionally, with partners from commercial, sales, supply chain, marketing, operations, etc.
  • Ability to work with limited supervision and take ownership of projects to meet scheduled timeline and technical goals; maintains accurate and thorough records
  • Experience writing SOPs and technical writing.
  • Ability to lead continuous quality system improvements for the validation program.
  • Data analysis such as Six-Sigma; ability to work in a cross-functional team environment Note: The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position.

Note: The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position
WHAT WE OFFER
Mativ benefits say a lot about how we care for each other. Our employees and their families have many different needs. As a result, our benefits offer choices on many levels and are high in quality, competitive in the marketplace, and affordable.
ABOUT MATIV
Mativ Holdings, Inc. is a global leader in specialty materials headquartered in Alpharetta, Georgia. The company connects, protects, and purifies the world every day through a wide range of critical components and engineered solutions that solve our customers' most complex challenges. We manufacture on three continents and generate sales in nearly 100 countries through our family of business-to-business and consumer product brands. The company's two segments, Filtration & Advanced Materials and Sustainable & Adhesive Solutions, target premium applications across diversified and growing end-markets, from filtration to healthcare to sustainable packaging and more. Our broad portfolio of technologies combines polymers, fibers, and resins to optimize the performance of our customers' products across multiple stages of the value chain. Our leading positions are a testament to our best-in-class global manufacturing, supply chain, and materials science capabilities. We drive innovation and enhance performance, finding potential in the impossible.

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