Senior Associate Facilities

Amgen; Thousand Oaks (CA); On-site; USD 90,000 - 122,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Annual bonus program

Stock-based incentives

Generous time-off

Job summary

Amgen Thousand Oaks is seeking a Senior Associate Facilities to provide maintenance leadership and technical expertise for drug substance facilities, equipment, utilities, and production suites. The role ensures systems operate within GMP guidelines and Amgen procedures, balancing production impact with reliability.

Responsibilities include prioritizing tasks with technicians, QA, and management, performing planned and corrective maintenance, and ensuring cleanroom work complies with GMP.

Qualifications

• Bachelor’s degree or equivalent with maintenance experience.
• 2 years of maintenance experience for certain levels, or 4+ years in GMP/regulatory environments.
• Experience with RCA facilitation or participation is preferred.
• Experience with reliability concepts (RCM/TPM) is preferred.

Responsibilities

• Plan, delegate, and oversee maintenance tasks to ensure compliant operations.
• Perform planned maintenance and emergency repairs of production facilities and utilities.
• Coordinate with QA and manufacturing to prioritize daily activities.
• Ensure cleanroom repairs follow GMP for no impact on production quality.
• Develop and maintain SOPs and job plans for facilities operations.
• Engage with vendors and internal teams to support facility equipment and utilities.

Skills

Maintenance leadership

Communication skills

Mathematical aptitude

Reading and comprehension

Computer skills

Education

Bachelor’s degree in a related field

Associate’s degree in a technical field

High school diploma / GED with maintenance experience

Tools

Power tools

Hand tools

Job description

Senior Associate Facilities

What you will do

Let’s do this. Let’s change the world. Amgen Thousand Oaks is looking for a Sr. Associate Facilities to provide maintenance leadership and technical expertise in support of Drug Substance facilities and their equipment/systems, utility systems, and/or production suites, ensures systems operate within crafted parameters. Area of responsibility may consist of multiple facilities, fields or clients. All work to be completed to assure minimal impact on production while following all cGMP guidelines and Amgen procedures.

Responsibilities include:

• Advising/planning/delegating of tasks to personnel in daily operations, corrective action, and preventative maintenance activities in a reliable and compliant manner to support multiple drug substance facilities.
• This includes the planned Maintenance and emergency repair of all production related facilities components including doors, working surfaces, permanently mounted equipment, facility lighting, equipment power supplies, and storage spaces.
• Works with a group of maintenance technicians, system owners, QA, and manufacturing management to prioritize daily activities.
• Responsible for ensuring repairs that are made within clean room spaces follow GMP regulations to ensure no impact to production quality and schedule.
• Maintains an environment that promotes maintenance flexibility, consistent maintenance practices, and efficient operations.
• Assist with development and maintenance of a working inventory control system for all spare parts requirements for the above-mentioned equipment.
• Be responsible for the development and revision of related Standard Operating Procedures, Job plans for area of responsibility to assure all maintenance operations have SOPs developed for them.
• Interact with various support departments and/or outside vendors and provide full maintenance support to meet the needs of the manufacturing groups for all related facility equipment for plant needs.
• Serve as an additional owner and SME for all water based critical utilities and support internal audits, regulatory audits and plant tours of utility spaces.
• Evaluate current maintenance procedures and make appropriate changes to optimize the maintenance program.
• Assure all corporate change control procedures are followed and Regulatory and QA are notified prior to the changes.
• Work to be completed in accordance with CFRs, cGMPs, SOPs and Amgen policies.
• Will participate in On-Call rotations for after-hours facility and Manufacturing support and may work outside of established shift hours upon short notice.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with the following qualifications:

Basic Qualifications

• Master’s degree OR Bachelor’s degree and 6 months of maintenance experience OR Associate’s degree and 2 years of maintenance experience OR High school diploma / GED and 4 years of maintenance experience

Preferred Qualifications

• 2 year technical/AA/AS degree in building maintenance, Mechanical maintenance, Plant engineering or related technical field
• 6+ years combined education and experience with 4+ years in an FDA (GMP) or comparable regulated environment
• Experience with RCA facilitation and participation
• Experience with RCM, TPM, or other reliability centered concepts
• Experience working in dynamic environments and facilities which follow FDA/GMP regulations.
• Knowledge of pneumatic, mechanical, and hydraulic fundamentals as well as skills in the use of power and hand tools in the building trades such as carpentry, plumbing, and electrical
• Effective oral and written communication skills
• Possess a high mathematical understanding, excellent reading skills along with intermediate to sophisticated computer and typing skills

What you can expect of us

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Salary Range 90,126.35USD -121,935.65 USD

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline: Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen