Process Engineer II

Work Location: Jaffrey, New Hampshire
Shift: No
Department: LS-SC-UJBBB Engineering DSP Front End Supervisor B
Hiring Manager: Matthew Gendron

This information is for internals only. Please do not share outside of the organization.

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

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.