Job Description

Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day!

of this Position:

The Operational Excellence (OpEx) Specialist II analyzes and measures the effectiveness of existing processes and helps to develop sustainable, repeatable, and quantifiable process improvements. The OpEx Specialist II will collect and analyze process/quality data to initiate, develop, and recommend operational practices and procedures that focus on enhanced safety, increased productivity, and reduced cost to drive overall quality. Also, coach, mentor, and train individual change agents and/or departments on how to drive their own improvement initiatives by using continuous improvement tools and methodologies. This is a fully on-site role.

Non-Negotiable Requirements:

• Bachelor’s and/or a minimum of 3-4+ years related work experience.
• 3-4+ years in continuous improvement role in a manufacturing or pharmaceutical industry; aseptic experience a plus.
• Prior experience teaching/facilitating Kaizen Events/Problem Solving Investigations.
• Prior experience participating in continuous improvement (lean or six sigma) teams.
• Proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements:

• Experience and expertise in pharmaceutical manufacturing with a thorough understanding of cGMP and FDA guidelines.
• Prior experience using MasterControl or other electronic quality systems such as Track Wise, SAP, etc.
• Ability to interpret and relate Quality standards for implementation and review.
• Knowledge of Manufacturing and QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• Knowledge of Process Improvement methodologies (e.g. Lean, Six Sigma).

Responsibilities Include (but are not limited to):

• Act as internal OpEx consultants to all levels and Departments within the organization.
• Teach and coach individuals on Continuous Improvement Tools and Methodologies.
• Coach and mentor individuals on how to drive their own improvement initiatives by using continuous improvement tools and methodologies.
• Engage as an OpEx facilitator for improvement initiatives that align with company goals and metrics.
• Develop continuous improvement plans/road maps for OpEx projects.
• Train personnel on Root Cause Analysis Investigation tools.
• Conduct advanced data analysis using statistical techniques, machine learning algorithms, and data visualization tools.
• Extract meaningful insights from complex datasets to inform business decisions and drive performance improvements.
• Translate data-driven insights into actionable recommendations and strategic initiatives.
• Facilitate projects to improve key problematic issues across the organization.
• Lead operational excellence efforts utilizing lean/continuous improvement methods and tools.
• Lead/facilitate standardization efforts of best practices across sites and departments.
• Lead and own change controls that would drive operational excellence efforts across sites.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

MEDICAL BENEFITS starting day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!

Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

PTO: Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

WELLNESS TIME OFF: Employees earn 1 hour of time off for every 30 hours worked to use how you choose.

PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!

PAY: Depends on Experience and is discussed during the interview process.

If you meet the required criteria listed above, GRAM welcomes you to apply today!