Maintenance Manager - Day Shift

Amgen•Holly Springs, NC

11d•Onsite

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is a leader in biotech, focused on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. We are building a new drug substance manufacturing plant, the Amgen FleX Batch facility, which will combine disposable technologies with traditional stainless-steel equipment. This facility will feature best-in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities and integrate sustainability innovations to reduce carbon and waste, aligning with Amgen's goal to be a carbon-neutral company by 2027. This role is vital for ensuring the reliability of GMP and non-GMP equipment at Amgen, North Carolina.

Requirements

High school diploma / GED and 10 years of maintenance and/or operations/manufacturing experience OR Associate’s degree and 8 years of maintenance and/or operations/manufacturing OR experience OR Bachelor’s degree and 4 years of maintenance and/or operations/manufacturing OR experience OR Master’s degree and 2 years of maintenance and/or operations/manufacturing experience OR Doctorate degree
Ability to adjust well in a fast pace working environment.
Ability to collaborate to solve issues and drive continuous improvements.
Demonstrated proficiency in process improvement methodologies.
Leverage a strong background in GMP Maintenance combined with excellent leadership and communication skills (written and verbal).
Ability to support multiple clients and prioritize resources against competing objectives.

Nice To Haves

Bachelor’s degree in life science, technical or aligned field of study
6+ years of relevant work experience in operations/manufacturing environment
3+ years of experience with regulated environments (i.e. cGMP, OSHA, EPA)
Managerial experience directly managing people and/or leadership experience leading teams
Experience working with ATO GMP F&E clients and systems (Bulk Manufacturing, Filling and Packaging, Supply Chain, Quality Labs, Small Molecule Manufacturing)
In-depth technical knowledge of GMP equipment and instrumentation
Experience supporting GMP capital project execution and verification activities
Demonstrated leadership attributes as an individual contributor (e.g., leadership of initiatives or participation on network level or continuous improvement teams)

Responsibilities

Provide technical and administrative leadership to a group responsible for planning/scheduling adherence, troubleshooting, repairing, maintaining, and improving the reliability of GMP and non-GMP equipment.
Establish team strategies, objectives, and goals, while improving team performance and consistently achieving key metrics/milestones.
Supervise and technically develop direct reports, and support Amgen’s continuous improvement culture.
Meet regularly with key clients to find opportunities and establish the strategic direction for the Maintenance Team.
Establish annual team goals and track progress / communicate to GMP F&E leadership team.
Develop staff through annual Career Development Planning and acting as a role model.
Improve team performance by conducting regular 1:1 meetings and using Maximizing Amgen’s Performance (MAP) process: regular coaching, mid-year and end of year reviews, compensation planning, and talent management planning.
Promote Operational Excellence and Safety through purposeful presence on the floor (Regular job task walk-through with staff members).
Partner with maintenance managers to improve Maintenance support as a member of the extended leadership team.
Provide Subject Matter Expertise to triage and resolve issues related to Maintenance process non-conformances.
Leverage knowledge of GMP F&E Process, Mechanical and Utility systems and instrumentation to develop team capabilities in diagnosis and troubleshooting of issues.
Manage lifecycle assessment and recommend replacement / upgrades as required to ensure high reliability.
Maintain awareness of relevant industry and regulatory trends for calibration / instrumentation and maintenance.
Provide input for responses to regulatory inspections or internal audits relating to instrument calibrations or maintenance programs.
Manage staff resources and work schedules (vacations, on-call rotation, etc.) to ensure adequate staff coverage and meet required PM calibration dates.
Ensure that staff maintain required training qualifications and are cross trained to support multiple GMP functional areas as needed.
Coordinate resources to support capital projects and work activities during maintenance shutdowns.
Manage department budget and expenses.
May require second or third shift work.