Validation Engineer 3

Merck Group • $105K — $115K *
Jaffrey, NH 03452In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in STEM or related field.
  • 5+ years of validation experience in FDA regulated environments.
  • Expertise in qualification of manufacturing and QC equipment.
  • Knowledge of ISO standards, cGMPs, and Good Engineering Practices.
  • Proficient in complex technical writing and analysis.

Responsibilities

  • Lead complex validations of equipment and processes in high purity filter production.
  • Collaborate with cross-functional teams for validation scheduling and execution.
  • Prepare and review validation documentation including CQV.
  • Assess vendor change notifications for impact on validation status.
  • Represent the Validation department in audits and provide actionable solutions.

Benefits

  • Health insurance coverage.
  • Paid time off (PTO) and retirement contributions.
  • Potential for performance-based bonuses.
Full Job Description
Your Role

The Validation Engineer III is an advanced level validation engineering position responsible for executing complex validations and qualifications of equipment, materials, processes and tests used in the production of high purity filters, prioritizing a focus on quality and safety. Responsible for establishing and maintaining qualification techniques. This position may lead lower-level engineers to ensure their projects meet validation standards. This role requires close collaboration with cross functional teams to assess risk, disposition product, resolve complex problems, and ensure projects and programs meet their expected objectives.

Duties Include:
  • Expert with Qualification and Validation of Manufacturing Equipment, QC equipment, raw materials, and Supply chain equipment including FAT, SAT, Installation and Operational Qualifications, and Performance qualifications (temperature mapping and process qualification).
  • Drive validation requirements needed for advanced manufacturing equipment design qualification and risk assessment to ensure that the equipment design is meeting manufacturer's specification and functional requirements.
  • Coordinate the scheduling of validation execution by collaborating with Manufacturing, Planning and Quality Control departments and analyze the test results against pre-determined acceptance criteria.
  • Prepare, maintain, and review Validation documentation such as CQV documentation for DQ, FAT, IQ, OQ, PQ, and process qualification.
  • Perform assessment of vendor change notifications to identify the impact of the change on validated status of equipment and GMP production. Review equipment calibration specifications and any out of tolerance records to determine the extent of failure on the validation test.
  • Represent the Validation department during internal and external audits.
  • Brings solution recommendations to management, assesses customer requirements, and studies product characteristics to select validation objectives and standards.
  • Provide guidance and mentorship to team members and contractors regarding cycle development and validation of complex manufacturing equipment and raw material changes.
  • Proficient at developing complex project plans to drive process improvements or changes, and capable of leading a cross functional team to meet deadlines. Able to anticipate challenges and roadblocks, and experiments with alternative and innovative solutions to avoid just refining existing solutions.
  • Highly skilled at building consensus with a cross functional team at all levels and converting vision into clear goals and milestones.
  • Facilitates effective teamwork by actively managing team dynamics. Anticipates challenges by utilizing knowledge / history to prevent issues from occurring.
  • Helps develop other experts by giving concrete advice, coaching, and mentoring on how to succeed in a business setting.
  • Leads Root Cause Analysis (RCA) and Corrective Action Preventive Action (CAPA) actions, implementing robust solutions to address root cause and prevent events from reoccurring.
  • Expert technical writing skills and strong understanding of Current Good Manufacturing Practices (cGMP).
  • Proficient at leading complex equipment and process validations activities, including protocol and report writing, review and execution.
  • Leads strategic or complex change requests in Change Management system, ensuring implementation solutions support operational needs and meet quality standards.
  • Anticipate roadblocks and challenges and navigate the team through problems to meet deadlines.


Physical Attributes:
  • Physical flexibility to interact with and troubleshoot machinery and equipment.
  • Exposure to chemical reagents.
  • Use hand and power tools.
  • Sit, stand, and walk for extended periods of time.
  • Frequent lifting/carrying of 26 - 50 lbs. Occasional lifting 75Lbs.
  • Bend, squat, stoop, and kneel.
  • Pinch, grasp, and manipulate objects consistently and regularly.
  • Fine motor skills.


Who You Are

Minimum Qualifications
  • Bachelor's Degree in STEM (engineering, sciences, or computer science, etc.), technical management, business management.
  • 5+ years of experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility or other regulated industry leading the validation of automated and manual assembly processes with working knowledge of ISO, cGMPs and Good Engineering Practices.


Preferred Qualifications
  • Master of Science Degree in STEM (engineering, sciences, or computer science, etc.), technical management, or business management.
  • Read and understand complex mechanical and electrical drawings and P&ID's.
  • Lean/Six Sigma experience, with a green or black belt certification.
  • Experience with HMI/PLC and preferred code knowledge.
  • Strong communication skills.
  • Manage and lead multiple projects and participate on cross-functional project teams.
  • Must be self-driven, able to work independently, and in teams with urgency.
  • Proven ability to analyze complex data sets, apply statistical analysis principles, and clearly summarize conclusions/results.
  • Familiarity with EH&S, ISO, cGMP, and other regulatory requirements in a manufacturing environment.
  • Experience with Microsoft products, Minitab, and CAD software packages.
  • Understand safe work practices and experience in lockout, tag out, electrical safety, etc.


Pay Range for this position: $105,000 -$115,000 annually

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.

Keep Up to Date

Stay informed with career tips, insider perspectives, and industry-leading insights from Merck Group professionals. These resources are invaluable for those looking to advance their careers and stay ahead in a competitive job market.

Job Alert Emails

Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences from Merck Group. Discover the exciting and rewarding career opportunities that await.

SEARCH MERCK GROUP JOBS

READ CAREERS BLOG

Merck Group is continuously looking for individuals who are ready to drive innovation and lead in the global marketplace. Whether through full-time positions, internships, or leadership roles, Merck Group offers a career path filled with opportunities for growth, learning, and leadership.
Learn more about Merck Group
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Merck Group

More Pharmaceuticals & Biotech Jobs

Find similar Validation Engineer 3 jobs:

NationwideJaffrey, NH