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HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Technical Writer, Manufacturing

Live

What you will do

Let’s do this. Let’s 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 Amgen’s 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.

Win

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:

High School Diploma / GED and 5 years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Or

Associate’s Degree in Science and/or Engineering and 2 years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Or

Bachelor's Degree in Science and/or Engineering.

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, investigations, CAPA’s and change controls.

• A fact-based problem solver with strong troubleshooting and problem-solving skills.

• Pro-active, result driven, and ability to prioritize work to meet deadlines.

• Good documentation and communication skills.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising 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 including:

• 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 and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.