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Process Engineer & Sr Process Engineer

Hudson, MA

Posted: 12/07/2022 Industry: Engineering and Technical Job Number: 15114

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.

Title: Process Engineer & Sr Process Engineer
 Hiring Organization: Connexion Systems & Engineering
  • Duration: Perm
  • Pay rate: $100-130k
  • Job Location: Hudson, MA
  • Job# 15114


Summary of the role
 Follows good manufacturing practices (GMP) and principles to develop robust manufacturing processes. Has a primary role in the engineering and validation of new products in the Biopharmaceutical assembly space but is also the subject matter expert for existing manufacturing operations in a clean-room environment.


Tasks and Responsibilities
  • Analyzes new product specifications and translates these into manufacturing processes to establish production rates, achieve expected quality levels and establish reliability of finished product.
  • Conducts reviews of new and revised mold tooling.
  • Acts as mold design review input champion.
  • Develops and optimizes polymer conversion process parameters for new tools.
  • Develops decoupled molding parameters to ensure process control.
  • Develops process parameters for secondary operations, including ultrasonic welding, bonding, and testing.
  • Conducts data analysis and collaboration with Project Engineering and Quality Engineering.
  • Perform Installation Qualifications (IQ) and Equipment Qualifications (EQ), as necessary.
  • Identifies Operational Qualification (OQ) process parameters and Performance Qualification (PQ) settings.
  • Develops and documents standard operating procedures (SOP) and product-specific operating procedures (PSOP).
  • Trains manufacturing personnel on SOPs and PSOPs.
  • Performs DOEs, and participates in the development of control plans, Process Maps, and PFMEA documentation.
  • Organizes internal cross-functional teams and corresponding outside vendors needed to meet project needs. Procures equipment as needed.
  • Uses standard problem-solving tools, e.g., 8D, 5 Whys, Fishbone.
  • Applies effective inter-departmental communication and escalation.
  • Owns tooling and process from a manufacturability standpoint from development to production release.
  • Partners with Quality department on investigation and corrective action for any failed First Article Inspection or OQ/PQ.
Process Engineer:
  • Provide mentorship to Process Engineers and Technicians
  • Autonomously directs team members to lead projects through to successful completion.
  • Provides mentorship to other Process Engineers and Technicians through experiences and education as opportunities arise 
  • Develops ideas and strategies to improve operational efficiency, add value, aid business performance and work towards a culture of continuous improvement
  • Successfully manages multiple high-profile projects simultaneously
Education and Experience
  • Required: 4-year degree in Industrial, Manufacturing, Plastics or Mechanical Engineering or a related discipline
  • 3-7 years of Biopharmaceutical processing or component manufacturing
Senior Process Engineer:
  • Required: 4-year degree in Industrial, Manufacturing, Plastics or Mechanical Engineering or related discipline
  • Lean Sigma Green or Black Belt certification
  • 7 years of experience in manufacturing engineering or related discipline
  • 7+ years of Biopharmaceutical processing or component manufacturing
Competencies
  • Ability to read, write, speak, and understand the English language
  • Ability to communicate clearly by conveying and receiving ideas, information, and direction effectively
  • Ability to demonstrate adequate job knowledge to deliver a world class performance
  • Ability to challenge oneself to consistently meet all goals and deadlines
  • Willingness to strive for excellence by producing work that is free of errors and mistakes
  • Desire to delight both customers and coworkers by offering encouragement, fostering teamwork, and addressing conflict appropriately
  • Commitment to making improvements company wide
  • Demonstrated competence using Microsoft Office
  • Use of statistical analysis software
  • Interpersonal skills and good communication technique
  • Ability to coordinate multiple projects and deadlines, manage and identify scope
  • Act as a project leader on major projects
  • Lean Manufacturing- Proficient in use of problem-solving tools such as 5 why, Fishbone, 8D, etc.
  • Understanding of manufacturing processes for medical components and devices.
  • Good understanding of metrology principles and methods.
Key Interfaces and Stakeholders
  • Co-workers
  • Managers
  • Customers
Geography to cover and Travel requirements
  • Minimal travel as required
Behavioral Characteristics
  • Customer Focus
  • Works with customers to build long term relationships & partnerships
  • Delivers on promises and commitments
  • Understands the impact of business decisions
  • Performance
  • Takes individual responsibility for personal objectives and results
  • Continuously improves performance by delivering on commitments
  • Encourages a culture of continuous improvement and teamwork
  • Sets clear objectives and measures performance by continuously soliciting feedback
  • Innovation
  • Develops innovative solutions to problems
  • Is proactive in initiating change and improvement
  • Shares knowledge and experience through teamwork
  • Continuously challenges by asking” why”
Responsibility
  • Respects the culture, custom and rules, our employees, suppliers, and customers
  • Communicates openly and accurately
  • Takes personal responsibility for actions
  • Performs all duties with commitments to excellence and integrity
EEO Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran, disability, or any other status protected by state or federal law.


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Meet Your Recruiter

Emily Donahue
Regional Recruiting Manager

  • Directthe recruitment efforts for both the Quincy, MA and Providence, RI branches. 
  • Manages a distributed team of recruiting leads, individual contributor recruiters and account managers. 
  • Responsible for leading the fulfillment and execution of sourcing, recruiting, sales and business development practices across the region. 
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