$ads={1}
This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.
Specific Job Duties:
- Act as aseptic guardian of Cleanrooms Grade A/B/C/D
- Guiding and training junior members of staff
- Act as delegate for shift lead/manager
- Ownership of monthly & annual trend reports, readouts & actions, including presentation the EM trends during audits
- Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
- Approve lab results
- Initiate and/or implement changes in controlled documents.
- Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
General job duties:
- Environmental Monitoring of Grade 8/9 Cleanrooms
- Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators
- Reading of Environmental Monitoring Plates
- Bioburden testing of water & disinfectants
- Water sampling
- Testing of In Process samples such as Protein Concentration, Density & pH
Basic Qualifications
- Bachelors degree in a science discipline
- Biopharmaceutical QC experience in a microbiology lab
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
- Experience working in an aseptic cleanroom performing Environmental Monitoring is absolutely necessary
Preferred Qualifications
- Proficient in the use of LIMS & LMES
- Experience in a senior role, providing guidance to team members
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
Competencies
- Technically strong background in microbiology and aseptic manufacturing
- Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
- Flexibility – the EM role often encounters changing priorities on a daily basis
- Problem solving skills
- Experience with Regulatory inspectors and interacting with inspectors desirable
- Demonstrated ability to work independently and deliver right first time results
- Works under minimal direction
- Work is guided by objectives of the department or assignment
- Follows procedures
- Refers to technical standards, principles, theories and precedents as needed
- May set project timeframes and priorities based on project objectives and ongoing assignments.
- Recognizes and escalates problems
- Auditing documentation and operation process
- Demonstrated ability to interact with regulatory agencies
Join Us
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney diseases, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
$ads={2}
