This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.

**Specific 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

+ Writing technical reports

+ Water sampling

+ Testing of In Process samples such as Protein Concentration, Density & pH

+ Initiate and/or implement changes in controlled documents.

+ Participate in audits, initiatives, and projects that may be departmental or organizational in scope.

+ Write protocols and perform validation and equipment qualification/verification.

+ Introduce new techniques to the lab, including method transfers, reports, validations and protocols.

+ Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.

+ Approve lab results

**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

**Preferred Qualifications**

+ Experience working in an aseptic cleanroom performing Environmental Monitoring

+ Proficient in the use of LIMS & LMES

+ Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

+ Biopharmaceutical QC experience in a microbiology lab

+ 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 disease, 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.

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