Manufacturing Process Engineer

Actalent • Vandalia, OH • 6d ago

Job Title: Manufacturing Process Engineer

Job Description

The Manufacturing Process Engineer will provide focused project leadership and technical support to Operations with an emphasis on project management, equipment qualification/validation, standard operating procedures, standard costing, capacity analysis, yield improvements, cost reduction, planning, validations, and metrology.

Responsibilities

Support production to maintain inventory flow and levels to meet demand.

Address issues such as NCR and CAPA quickly and effectively.

Plan, lead, and execute cross-functional projects impacting operations and other business areas with guidance.

Lead continuous improvement activities focusing on productivity, quality, cost, cycle time, and yield of raw material.

Lead efforts to maintain and improve the quality of existing operations, processes, and products.

Analyze existing and new processes and improve them using Lean Six Sigma tools such as spaghetti diagram, process maps, and SIPOC.

Represent operations on new product development teams and develop and implement associated processes.

Essential Skills

Bachelor's degree in engineering, preferably biomedical.

3+ years of relevant experience in a highly regulated environment such as medical device, automotive, or aerospace.

Experience in technical and report writing, which constitutes 90% of the job.

Knowledge of Medical Device Manufacturing, GD&T, QMS, ASQ, Six Sigma, and tissue processing.

Understanding of validation, cGMP, GMP, regulatory standards, audit processes, root cause analysis, process engineering, process improvement, and CFR Part.

Proficiency in Microsoft Office Suite, especially Excel for creating formulas and basic to intermediate functions.

Additional Skills & Qualifications

Experience in biologics, biomedical, medical device manufacturing, or tissue manufacturing.

Teamwork-oriented individual who can drive themselves and take ownership.

Mechanical, chemical, biomedical, or industrial engineering background preferred, though other disciplines are considered.

Experience with lean manufacturing and/or process controls.

Tissue experience preferred.

Master's degree is a plus.

Willingness to process and handle human and animal tissue-based products.

Work Environment

The position adheres to a business casual dress code within a clean room environment. The standard work hours are from 8 AM to 5 PM, comprising a 40-hour workweek.

Pay and Benefits

The pay range for this position is $36.00 - $45.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Vandalia,OH.

Application Deadline

This position is anticipated to close on Jun 12, 2025.

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