Operations Technical Specialist I/II/III

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:

Execute routine technical support activities for GMP Manufacturing Operations across multi-product, Manufacturing, Fill, and Finish CDMO facilities. Activities include cross-functional deviation investigations, CAPAs, AIs, targeted innovations, audit support, and overall plant performance.

Non-Negotiable Requirements:

• Bachelor's degree in life sciences or equivalent training and/or experience is necessary.
• 3 or more years of relevant experience in pharmaceutical manufacturing is required.
• Strong skillset in root cause analysis, technical writing, and CAPA in a GMP environment and/or related LEAN/six-sigma experience.
• Must have proficient computer skills in Microsoft Word, Excel, and Outlook.

Preferred Requirements:

• Previous experience in a CMO and sterile filling, manufacturing, and/or fill finish environment.

Responsibilities Include (but are not limited to):

• Author and revise site procedures in a timely manner to address CAPA and corrective actions for deviation investigation and/or site continuous improvement projects.
• Assist in implementation of targeted new technologies and procedures.
• Assess, evaluate, and provide immediate corrective actions for GMP discrepancies and intra batch process monitoring, analysis, and reporting.
• Serve as first line of defense for all operations excursions, GMP lifecycle management of execution level process data, providing for unit operation (i.e., formulation, manufacturing, sterile filling, inspection/labeling).
• Support strategic plans for process and plant improvements to increase efficiency and manage costs.
• Work closely with respective team members from Operations, Engineering, Maintenance, Project Management and Quality to ensure all documentation (and respective data) is gathered in an expeditious manner for timely completion of deviation investigations.
• Ensure appropriate risk analysis, root cause and corrective action tools and identification is used for all deviation investigations.

Full job description available during formal interview process.

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!

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!