Process Engineer II

Merck Group$77K — $130K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in relevant engineering discipline (Mechanical, Manufacturing, Industrial, Controls)
  • 2+ years of experience in FDA regulated manufacturing
  • Proficiency in troubleshooting critical manufacturing equipment
  • Understanding of cGMP, ISO, and regulatory requirements
  • Ability to analyze data sets and apply statistical principles

Responsibilities

  • Support the manufacture and testing of high purity filters while ensuring safety and quality
  • Monitor machinery and tools to verify efficiency and investigate issues
  • Facilitate decision-making and consensus-building among cross-functional teams
  • Evaluate and implement process improvements to meet deadlines
  • Conduct Process Engineering assessments and lead RCA and CAPA initiatives
  • Manage capital equipment purchases, overseeing fabrication and validation
  • Design statistically controlled manufacturing processes and mentor team members

Benefits

  • Health insurance
  • Paid time off (PTO)
  • Retirement plan options
  • Eligibility for performance-based bonuses
Full Job Description
Your Role

The Process Engineer II is an intermediate level engineering position responsible for supporting the manufacture and testing of high purity filters, prioritizing safety and maintaining a focus on quality, process control, electro-mechanical assembly, and material handling. Responsible for establishing operating specifications and implementing and improving manufacturing techniques. Closely monitors performance of machinery, automated equipment, and tools to verify their efficiency and investigates and initiates corrective action for challenging problems and deficiencies to ensure product quality. This position ensures process stability with a focus on maximizing safety, quality, yields, and productivity and requires collaboration with cross functional team to assess risk, disposition product, and resolve problems. Duties Include:
  • Proficient at maintaining efficiency and upkeep of critical manufacturing equipment through effective troubleshooting techniques. Able to diagnose and resolve intermediate level process problems.
  • Exchanges ideas with other team members and leads technical discussions to realize process improvements and changes.
  • Leads decision making by building consensus among cross functional peers.
  • Proficient at evaluating and implementing process improvements or changes and driving a cross functional team to meet deadlines.
  • Independently conducts intermediate-level Process Engineering assessments using data to ensure proper product disposition, leads or supports Root Cause Analysis (RCA) and CAPA initiatives with robust, preventive solutions, and demonstrates strong technical writing skills and a solid understanding of cGMP standards.
  • Leads capital equipment purchases by generating robust justifications, managing timelines and spend activities, and overseeing fabrication, installation, and testing to meet industry and user requirements; generates, reviews, and approves engineering, manufacturing, and quality procedures to support equipment validation, launch, and production operations.
  • Coordinates equipment and process validations activities, including protocol and report writing, review and execution.
  • Designs and develops statistically controlled manufacturing processes, leads change requests to align implementation with operational and quality standards, advances systems to mitigate failure modes and scrap risk, navigates implementation challenges, and fosters effective teamwork by mentoring and collaborating across levels.


Physical Requirements
  • Physical flexibility to interact with and troubleshoot machinery and equipment.
  • Exposure to chemical reagents.
  • Sit, stand, and walk for extended periods of time.
  • Frequent lifting/carrying of 11-25 lbs., Occasional lifting/carrying of 26 - 50 lbs.
  • Bend, squat, stoop, and kneel.
  • Pinch, grasp, and manipulate objects consistently and regularly.
  • Excellent fine motor skills.


Who You Are

Minimum Qualifications
  • Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or Controls Engineering.
  • 2+ years of experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility or other regulated industry supporting automated or manual assembly processes.


Preferred Qualifications
  • Masters of Science Degree in Electrical, Mechanical, Chemical or Industrial Engineering.
  • 2+ years of experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility or other regulated industry supporting automated or manual assembly processes.
  • Electro-Mechanical, instrument and pneumatic knowledge along with 3+ years of experience applying this knowledge to process/equipment design and/or troubleshooting.
  • Proven ability to analyze intermediate level 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.
  • Read and understand intermediate level mechanical and electrical drawings and P&IDs.
  • Experience with Microsoft products, Minitab, and CAD software packages.
  • Understand safe work practices and experience in lockout, tag out, electrical safety, etc.
  • Lean/Six Sigma experience, with green or black belt.


Pay Range for this position: $77,900.00 - $130,900 .00 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

RSREMD

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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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.
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