Validation Engineer 2

Merck Group$84K — $127K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's or Master's degree in relevant engineering/science field with applicable experience
  • 4+ years experience in process or product development/validation (B.S.) or 3+ years (M.S.)
  • 2+ years experience with FMEA/risk analysis and root cause analysis
  • 3+ years experience with process/product validations and Good Documentation Practice
  • Hands-on experience with test method development and execution

Responsibilities

  • Author validation test protocols and manage the execution and analysis
  • Participate in product development and creation of specifications
  • Collaborate with cross-functional teams on product changes and customer applications
  • Design and develop new testing methods and equipment for product validation
  • Interact with various departments including R&D, Quality, and Operations

Benefits

  • Health insurance coverage
  • Paid time off (PTO)
  • Retirement contributions
  • Potential eligibility for sales or performance-based bonuses
Full Job Description
Your Role:

MilliporeSigma in Bedford, MA is hiring a Product Validation Engineer 2. As a member of the R&D Validation & Applications Center (VAC) Engineering team, you will actively participate on filtration product development teams to understand the new product and its applications. Your contribution includes development and implementation of an efficient and thorough validation test strategy which ensures robust product performance specifications based on product design and intended applications.

Responsibilities:
  • Authoring the validation test protocol, managing lab test requests, test execution, data analysis and authoring the report
  • Participate in process and product development supporting DOE studies and data analyses and creation of the product design specifications and risk assessments
  • Collaborate with Operations, Product Management, and Field Marketing to aid in product/process change requests, raw material qualifications, and customer applications
  • Hands-on design and development of new test methods, test equipment, and measurement systems which are utilized to characterize and validate new products, including troubleshooting, repairs, and identifying and implementing equipment upgrades/new technology and planning, documenting, and executing test method validations
  • Effectively interact with other groups, such as R&D development teams, Quality, Manufacturing, Engineering Services, Facilities, EHS, and Finance.


This position may include occasional travel to our manufacturing facilities

Who You Are

Minimum Qualifications:
  • Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Physics, Materials Science or other Engineering or Scientific field with 4+ years of experience in process or product development/validation

-OR-
  • Master's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Physics, Materials Science or other Engineering or Scientific field with 3+ years of experience in process or product development/validation

-AND-
  • 2+ years of experience with FMEA/risk analysis, product failure and root cause analysis
  • 3+ years of experience with process and product/equipment validations (IQ/OQ/PQ), authoring formal protocols and reports utilizing Good Documentation Practice (GDP)


Preferred Qualifications:
  • Experience in Medical Device or Life Science industries
  • Experience with filtration and chromatography products
  • Experience with Product Development Process (PDP) and working on cross functional teams
  • Experience in statistical analysis tools such as Capability, Gage R&R, DOE using Minitab
  • Capable in the development and execution of test method validations
  • Knowledge of applicable FDA Regulations, USP requirements, Regulatory requirements for products used in biopharmaceutical/med device industry
  • Experience in equipment troubleshooting and repairs


Pay Range for this position: $84,900 - $127,300

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

About Merck Group

Merck Group Careers

There has never been a more opportune time to join Merck Group, a leading science and technology company in healthcare, life science, and performance materials. Merck Group offers a plethora of job opportunities that cater to a variety of skills and professional aspirations, making it an ideal environment for both seasoned experts and those at the start of their career journey.

Work You’ll Do

At Merck Group, every team member contributes to breakthrough innovations in healthcare, life sciences, and electronics. The company's commitment to diversity and innovation fuels its leadership in various sectors, driving growth and transformation globally. Merck Group’s career paths are diverse, offering positions that challenge individuals to use their skills in new ways every day, supported by robust training programs and development opportunities.

Explore Job Opportunities and Growth

Merck Group is not just about jobs; it's about building a career. With a vast array of positions, from research and development to marketing and sales, the company is keen on hiring and nurturing talent to lead industry transformation. Merck Group’s dedication to professional growth is evident in its comprehensive benefits package and performance management processes that aim to maximize individual potential.

Internship Programs

Starting with an internship at Merck Group can be a pivotal step in securing a prosperous career. Interns gain invaluable industry experience, working alongside seasoned professionals and engaging in projects that offer real-world applications of their studies. Internships often lead to full-time employment opportunities, providing a seamless transition from education to professional employment.

Inclusive Culture and Leadership

Merck Group is proud of its inclusive culture that embraces diversity and fosters an environment where all employees can thrive. The company’s leadership is committed to creating a workplace where diverse ideas lead to innovative outcomes. Merck Group also offers diversity training to ensure all team members are equipped to contribute to the company’s inclusive goals.

Networking and Professional Development

Employees at Merck Group are encouraged to engage in networking and professional development activities that enhance their career trajectories. The company hosts various networking events, workshops, and seminars that are designed to hone skills and foster connections within the industry. Leadership development programs are also a cornerstone, preparing employees for future roles of increased responsibility.

Stay Connected with Merck Group Careers

Interested candidates can explore open positions that match their skills and interests through the Merck Group careers page. The company values curious, creative, and solution-driven team players who are eager to make an impact.

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