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:

The Senior Manufacturing Process Engineer leads technical projects for GMP Manufacturing Operations across multiple sites. Drives process optimization efforts, implementing solutions and strategies for new technical problems, providing troubleshooting guidance, and contributing to continuous improvement initiatives that ensure the manufacturing of quality drug product in compliance with cGMPs and governing agencies. Participates in cross-functional collaboration for a multi-product CMO facility that includes activities related to compliance, quality, targeted innovation, and plant performance and success.

Non-Negotiable Requirements:

• Bachelor’s degree in mechanical or electrical engineering, automation, or life sciences OR equivalent work experience.
• Prior education and relevant engineering experience: Master’s degree with 3 years of relevant experience, OR Bachelor’s degree with 5 years of relevant experience, OR 9 years of relevant training and/or experience.
• Proficient computer skills in Microsoft Word, Excel and Outlook.
• Available for off-shift and/or on-call work, as needed.

Preferred Requirements:

• 7 years in a production engineering role, or 7 - 9 years of relevant experience in pharmaceutical manufacturing or a laboratory environment.
• Previous experience in a CMO and/or sterile pharmaceutical manufacturing.

Responsibilities Include (but are not limited to):

• Commitment to expand knowledge of current and emerging advancements in technology, communication skills, and processes techniques.
• Lead implementation of targeted new technologies and procedures.
• Work with the Project Management, MSAT, and Validation groups to transfer new products to production.
• Provide mentoring for other technical and production staff. May include direct supervision of interns and consultants.
• Understand what departments are accountable for specified deliverables and set clear expectations for them on projects.
• Communicate clearly and act professionally with clients.
• Initiate and lead actions from Change Control and CA/PA projects for the manufacturing department.
• Assess, evaluate, and provide corrective actions for cGMP discrepancies.
• Monitor batch process data, analyze data set, and generate applicable reports.
• Share expertise to ensure equipment in functional area is maintained and operational. Work hands on with advanced aseptic fill/finish technologies with some flexibility for on-site support during critical operations.
• Execute minor preventative maintenance (PM) activities. Provide support for more advanced PMs executed by the maintenance department and outside vendors.
• Lead process optimization and troubleshooting for processes involving the use of production equipment and software.
• Follow SOPs in their functional area and provide feedback to others when opportunities to improve compliance are observed.
• Institute programs to minimize human error, mechanical failure, environmental contamination, and procedural deviation.
• Lead process and plant improvements to increase efficiency and manage costs.
• Author update, and review changes to SOPs, forms, and specifications.
• Effectively collaborate with manufacturing, quality assurance, facility engineers, MSAT, microbiologists, project managers, and senior management team.
• Provide guidance to facility engineering and validation during upgrades of clean room spaces and utilities.
• Take corrective action by thinking creatively to solve problems and develop innovative solutions based on sound science and engineering analysis.
• Thrive in a flexible and fluid work environment.
• Support multi-shift operations, training, and testing.

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.