Associate Manufacturing Process Engineer

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:

The Associate Manufacturing Process Engineer is responsible for assisting with driving process optimization efforts, implementing solutions and strategies for new technical problems, providing troubleshooting guidance, and contributing to continuous improvement initiatives that ensures the manufacturing of quality drug product in compliance with cGMPs and governing agencies. They will participate 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:

• Education in the fields of mechanical engineering, electrical engineering, automation, or life sciences. Examples include master's degree, bachelor's degree, or 4 years of relevant training and/or experience.
• Ability to manage multiple projects and deliver solutions on-time and in alignment to the project schedule.
• Strong communication skills with the ability to articulate questions and communicate needs.
• Effective in verbal and written communication, with a willingness to present.
• Proficient at technical writing.
• Ability to work with Microsoft Word, Excel and Outlook.

Preferred Requirements:

• Prior experience in a CMO and/or sterile pharmaceutical manufacturing.

Responsibilities Include (but are not limited to):

• Learn pharmaceutical industry best practices and GRAM manufacturing/finishing operations.
• Support actions from Change Control and CAPA projects for the manufacturing department.
• Assist with corrective actions for cGMP discrepancies.
• Monitor batch process data, analyze data set, and generate applicable reports.
• Develop knowledge of equipment in functional area. 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.
• Support advanced PMs executed by the maintenance department and outside vendors.
• Participate in process optimization and troubleshooting efforts for production equipment and software.
• Communicate with leadership on solutions that can be developed to minimize human error, mechanical failure, environmental contamination, and procedural deviation.
• Support process and plant improvements to increase efficiency and manage costs.
• Update SOPs and forms to improve processes.
• Effectively collaborate with manufacturing, quality assurance, facility engineers, MSAT, microbiologists, project managers, and senior management team.
• Open to a flexible and fluid work environment.
• Execute assignments as directed to support multi-shift operations, training, and testing.
• Perform job responsibilities in compliance with regulations, standard operating procedures, and industry best practice.

What Sets GRAM Apart from Other Employers:

MEDICAL BENEFITS starting day 1: medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% 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.