Senior Associate Facilities

BioSpace; Thousand Oaks (CA); Sur place; USD 110 000 - 140 000; Plein temps

Résumé du poste

Amgen Thousand Oaks is seeking a Senior Associate Facilities to provide maintenance leadership and technical expertise for drug substance facilities and related equipment. You will ensure systems operate within cGMP guidelines while coordinating with QA, manufacturing, and facilities teams.

You will develop SOPs, manage spare parts, and support internal and regulatory audits. The role requires strong communication, problem-solving, and hands-on maintenance experience in regulated environments.

Qualifications

• Masters degree or equivalent in a relevant field.
• Bachelor's degree and 6 months of maintenance experience or higher.
• Associates degree and 2 years of maintenance experience or higher.
• High school diploma / GED and 4 years of maintenance experience.

Responsabilités

• Advising/planning/delegating tasks to maintenance staff to support production.
• Perform planned maintenance and emergency repair of facilities components.
• Prioritize daily activities with QA and manufacturing management while ensuring GMP compliance.

Connaissances

Maintenance leadership

cGMP knowledge

Communication skills

Mechanical fundamentals

Tools proficiency

Formation

Master's degree

Bachelor's degree

Associate degree

High school diploma

Outils

Power and hand tools

Description du poste

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Associate Facilities

What you will do

Lets do this. Lets 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

Basic Qualifications

• Masters degree OR
• Bachelors degree and 6 months of maintenance experience OR
• Associates 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

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

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.

In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include

• 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.

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

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.