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.

Job 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.

Senior 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 Requirements:

Process Engineer:

• 4-year degree in Industrial, Manufacturing, Plastics or Mechanical Engineering or a related discipline
• 3-7 years of process design and validation experience. Preferred experience with Biopharmaceutical products.

Senior Process Engineer:

• 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 process design and validation experience. Preferred experience with Biopharmaceutical products.

Competencies:

• 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
• 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
• Ability to coordinate multiple projects and deadlines, manage and identify scope

This job description is not intended to be all-inclusive. Employees may perform other related duties as required to meet the ongoing needs of the organization.

Job Types: Full-time, Permanent

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Experience level:

• 4 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Ability to commute/relocate:

• Northborough, MA 01532: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Do you have a Lean Sigma Green or Black Belt Certification?
• Do you have experience in the Biopharma industry? If so, how many years?

Education:

• Bachelor's (Required)

Experience:

• process design and validation: 3 years (Preferred)

Work Location: In person

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