Specialist - Manufacturing - Engineering Support Job New Albany area,Indiana USA,Manufacturing / Production

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 illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

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.

What you will do

Lets do this. Lets change the world! In this role you will support the manufacturing team and provide technical expertise to regularly draft and revise documents such as Standard Operating Procedures (SOP'S), Work Instructions (WI), protocols, technical reports, and training material in a GMP regulated environment that supports the manufacturing process.

This role will also lead and own quality records such as deviations, CAPAs, Change Controls, and Quality Risk Management and provide expertise in Amgens Quality Management System (QMS).

Responsibilities may include, but are not limited to:

Develop, review, and update technical content including but not limited to SOPs, WIs, risk assessments, protocols & reports for manufacturing team.
Generate, own, and provide subject matter expertise to Quality System records as minor/major deviations, CAPA and change control records.
Provide technical and clerical support to the manufacturing team in the preparation of documentation, collation of data and tracking of technical documents.
Liaise with manufacturing team and other cross functional departments regarding documentation changes in an effective and timely manner.
Collaborate with multiple departments to support new/revise training documentation for manufacturing staff.
Support process owners and participate in continuous process improvement and / or troubleshooting projects.
Support manufacturing team in reducing document turnaround times.
Ensure documentation related actions are completed on time and current schedule is maintained, accurate, and up to date.
Develop protocols for execution in Manufacturing to support change controls, deviations & troubleshooting investigations with provision from relevant SMEs.
Track pending activities required to support change control implementations.
Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current operating systems.
Share knowledge with members of the manufacturing team.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

Basic Qualifications:

Doctorate degree

Masters degree and 2 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Bachelors degree and 4 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Associates degree and 8 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

High school diploma / GED and 10 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Preferred Qualifications:

Educational Background in Science and/or Engineering.
Experience working in GMP pharma and/or biotechnology industry.
Experience in a Good Manufacturing Practices (GMP) environment and solid background in technical writing.
Experience with device assembly and packaging of final product.
Ability to translate highly technical information into easily understandable information for manufacturing operators.
Creative skills and usage of photographs, drawings, diagrams, animation, and charts that increase users understanding.
Experience supporting deviations,…