Aseptic Process Engineer Jobs in Michigan (NOW HIRING)

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!

Overview of this Position:

Production Management: Manage all preparation, formulation, and sterile filling activities so that the site meets customer needs and department objectives (quality, cost, service, safety). Ensure workflow optimization and implement processes for manufacture of new products, understand changes in business needs and align accordingly. Ensure acceptable quality of all products and maintain global regulations and standards. Make sure equipment and personnel is available, qualified and ready. 

Continuous Improvement: Lead a culture of operational excellence using OPEX principles and tools to increase productivity and efficiency and decrease cost. Continuously look for new, innovative ways, provide recommendations for new equipment and processes that lead to an efficient and effective production environment. Develop and maintain systems for all elements of OPEX. Develop processes to meet changing business needs that are sustaining and adaptable.

Build Production Capabilities: Translate the site's strategic plan to a long-term production plan (facilities, processes, systems, capacity plan) and recommend technology and equipment to be used for specific operations. Design and modify practices and procedures when necessary, to make gains in quality, cost, service, and safety.

People Management: Look after the well-being, safety and health of the workforce. Ensure employee's engagement and motivation to function successfully by fostering a team-based and caring environment and by being visible to all staff. Drive employee enablement and ensure proper training is provided to guarantee certified, competent staff to accomplish the required tasks.
Build People Capabilities: Translate the site strategic plan to develop a workforce plan (capabilities, roles, headcount, culture) and the packaging management team to balance structural effectiveness with flexible capabilities and build OPEX behaviors at all levels. Empower the team to ensure the ability to manage the day-to-day activities and problems as well as uncertainty and changing business needs. Create an environment that encourages the shop floor employees to raise efficiency ideas and projects.

Non-Negotiable Requirements:

• Bachelor's degree in Life Sciences/Engineering or in another relevant field.
• Minimum of 10 years of experience in a lean/OPEX production environment with demonstrated, sustained performance improvements.
• Minimum of 10 years of Management experience in a cGMP environment in the pharmaceutical, biotech, or other regulated manufacturing environment.
• Minimum of 5 years leadership experience: an inspiring and enabler leader who creates opportunities for growth.
• Six Sigma and Lean application experience with extensive knowledge of tools and proven positive outcomes.

Responsibilities Include (but are not limited to):

• Continue to develop the skillset and knowledge base of the Manufacturing team to improve right first-time targets utilizing coaching and mentoring skills, emphasizing adherence to cGMP requirements.
• Develop actionable metrics to trend and track KPI's and provide corrective actions for variations.
• Work closely with the Quality team to decrease planned downtime while improving quality KPI's.
• Collaborate with other departments to involve front line personnel in kaizen events to improve processes.
• Partner with cost accounting to develop standard costs and evaluate trends for areas of opportunity.
• Promote the continuous improvement of GRAM's culture to align with the overall strategies of the department and the Company.
• Proactively work with HR, Manufacturing Managers, and Training Coordinator to develop new hire strategies and effective training processes to educate and retain top talent.
• Utilize direct reports to create cross functional training modules to educate technicians to better understand processes and improve decision making skills.
• Collaborate with Engineering to enhance current equipment to improve quality and efficiencies.
• Working closely with EHS, promote safety first and increase the OSHA knowledge base of the front-line Associates.
• Build trust in the department with peers to increase collaboration and successful outcomes.
• Must manage shifting priorities in a dynamic operations setting.
• Assist and oversee the process of purchase, onboarding, and qualification of production equipment.
• Provide input of CAPAs in response to adverse events.
• Foster a positive team environment that promotes productivity and employee satisfaction.
• Exhibit professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Open to a flexible and fluid work environment. Work on any assignment as directed and flexibility to support limited multi-shift operations.
• Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.

What Sets GRAM Apart from Other Employers:

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!

PAID TIME OFF: You choose how to use this time for your vacation, sick, or mental health needs! PTO: Full-time employees accrue up to 104 hours of paid time off per calendar year, with this amount being prorated your first year. WELLNESS TIME OFF (WTO): In addition to PTO, employees earn 1 hour of wellness 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.