What are the responsibilities and job description for the Validation Engineer position at Mativ Holdings, Inc.?
Description
Position Title:Validation Engineer
Location:Dallas, TX
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 andqualification, manufacturing process validation, as well as cleaning validation, and ensuring
systems remain in a qualified, operational state of compliance associated with cGM
manufacturingwork environment.
Generates, reviews, and executes the master validation plan, validation protocols (IQ, OQ, PQ) on
equipment, utilities, and computerized systems ensuring compliance with cGMP,
Applies concepts of Continuous Monitoring through Statistical Process Control (SPC) to ensure
the processes that have been transferred into production are being 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
Evaluates 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
Resolves CAPA's, nonconformances, protocol incidents, and change controls related to validation
protocols
Generates data and reports for the validation periodic monitoring and re-qualification programs
Establishes 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.
Communicates 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.
Performs 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)
Assists 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.
Stays current with regulatory trends and validation best practices to enhance validation strategies.
Writes 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.
OTHER SKILL SETS:
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
WHAT WE OFFER:
As a Mativ employee, you'll have access to a variety of benefit programs designed to help you no matter your stage of life.
Medical, dental and vision insurance
Consumer-Driven Health Plan (CDHP)
Preferred Provider Organization (PPO)
Exclusive Provider Organization (EPO)
Company-paid basic life insurance and Additional voluntary life coverage
Paid vacation and competitive personal time off
401(k) savings plan with company match
Employee assistance programs - available 24/7 to you and your family
Wellness and Work Life Support - career development and educational assistance
This role is also short-term incentive plan eligible. This posting will close within 90 days of the date posted. We encourage you to apply now!
ABOUT MATIV:
Mativ Holdings, Inc. is a global leader in specialty materials headquartered in Alpharetta, Georgia. The company makes material impacts on 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.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or other protected status and will not be discriminated against on the basis of disability. SWM International is committed to help individuals with disabilities participate in the workforce, and ensure equal opportunity to compete for jobs.
