Sr. Associate - F&E Compliance

Career Category

Job Description

Sr. Associate F&E Compliance – L4 - Amgen Dun Laoghaire

Overview:
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients.  ADL activities include Biopharmaceutical Aseptic Manufacturing, Lyophilisation and Automated Inspection & Packaging.

Live
What you will do

Let’s do this. Let’s change the world.  The position holder will be a key member of the Facilities Team, supporting the delivery of a diverse range of services across the Amgen Dun Laoghaire site with specific responsibilities for area compliance and standardized processes. The role has responsibility for leading the delivery of several facility programmes and providing consistent cross-functional support to various site stakeholder groups. The position will report to the Sr. Mgr. Engineering responsible for the Facilities Department.

Key Duties and Responsibilities:
•    Pest Control Programme System Owner.

o    Managing pest control vendor relationship.

o    Analysing vendor reports and creating monthly compliance reports.

o    Ensuring layout drawings are accurate and maintained.

o    Represent ADL as SME on the global network team.

o    Present to regulatory agencies on the Pest Control Programme.

 
•    Accountable for general compliance activities and procedures within the Facilities Department.
o    Support the compliance of integrated service providers with safety processes and procedures.
o    Managing the content and revisions of applicable area SOP’s .
o    Coordinate the tracking of relevant safety metrics, INCA’s/CAPA’s and team training requirements.

•    Quality and GMP  
o    Auditing documentation and process flows to ensure compliance with expectations and procedures.
o    Assist in the management of Quality Records – e.g. minor deviations.

•    Access Control System
o    Assist with quarterly compliance reviews and documentation updates.
o    Ensure associated site layout drawings are accurate and maintained.

•    Procurement
o    Assist in raising purchase requestions and processing invoices for key service providers.

•    Support the coordination of broader facility management services. 

o    Collation of capacity data for site.
o    Act as departmental SME for local systems such as the desk booking app and locker management.
o    Participate in the site zone inspection programme. 
o    Management of the Facilities Sharepoint site.
o    Assist in the prioritisation and delivery of local of department projects.
o    Day to day management of communications to internal stakeholder groups.

•    Support the operation of the site gym and wellness facilities.
•    Assist with coordinating site events/logistics and evolve service offerings onsite as the site population changes.

Win
What we expect of you

The successful candidate for this role will bring the following education, skills and experience.

Basic Qualifications & Experience:
•    Bachelors’ degree in a technical subject or equivalent qualification and experience.
•    At least 1-3 years' experience in a GxP or other highly regulated manufacturing environment.
•    Self-motivated, organised individual with the ability to take on several projects at one time.
•    Strong communication and technical writing skills with an eye for detail.
•    An effective team player working as part of a cross functional group.

Preferred Qualifications & Experience:
•    Experience in pharmaceutical/biotech or facility management industry.
•    Ability to build working relationships and effectively partnerships at all levels in the organization. 
•    Excellent oral and written communication, facilitation, organizational and planning skills. 
•    Quality systems management (e.g. Non-Conformance, Change Control, CAPA).
•    Basic computer skills (e.g. MS Office, Power BI Applications).
•    Experience in Pest Control Management Systems and interacting with regulatory agencies.
•    Fundamental knowledge of applicable regulatory requirements (GxP & EHS).

Thrive
What you can expect of us 

In addition to a competitive salary structure, Amgen offers a generous Total Rewards Plan for staff and eligible dependents. Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance.  Discretionary annual bonus program. Exceptional learning, development and career advancement opportunities, empowering employees to grow and build long-term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development.

Amgen is an equal opportunities employer