Manufacturing Specialist-Operational Readiness
Manufacturing Specialist-Operational Readiness
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 139179 - 139179
1 Vacancy
Job Description
Career Category
ManufacturingJob Description
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 illnessesdrives 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. 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 awardwinning 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.
Manufacturing SpecialistOperational Readiness
What you will do
Lets do this. Lets change the world. This role will support the of manufacturing/quality systems through leading manufacturing process/procedures risk assessments continuous improvement initiatives training and new product introductions. They will apply process operation compliance analytical and troubleshooting skills along with scientific and technical expertise to support Amgen Ohios operations.
Responsibilities may include but are not limited to;
- Primary point of contact to support operations and the organization through planning designing monitoring and optimizing manufacturing processes.
- Serve as the Subject Matter Expert (SME) for documentation specifically responsible for initiating revising and/or approving technical content and manufacturing procedures (SOPs WIs Risk Assessments Protocols & Reports) to ensure all procedures reflect current operations regulatory requirements and quality standards.
- Collaborate with key crossfunctional teams including but not limited to Quality Engineering Capital Project Process Development Supply Chain and Business Operations to ensure timely and accurate delivery of projects and final packaged products.
- Assist with process/equipment design and the of the process validation and generation of process validation protocols and reports.
- Participate in technology transfer/NPI process to assess requirements for documentation materials training and equipment modifications.
- Assist in generating training materials and/or provide training on scientific and technical aspects of our packaging process.
- Support process monitoring quarterly reports requiring detailed data collection understanding of process monitoring parameters and control limits and evaluating results against site KPIs.
- Participate in continuous improvement initiatives such as lean manufacturing six sigma and kaizen.
- Create and lead through Quality Systems records such as deviations and CAPAs providing review of manufacturing process equipment and systems during root cause analysis (RCA) investigations and trend evaluations.
- Provide impact and risk assessments for Change Control Review Board (CCRB) records as the change control owner.
- Drive process or equipment modification projects which must be thoroughly assessed prioritized justified and completed in an efficient manner.
- Manufacturing SME and point of contact to participate in regulatory inspections/audits.
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
Or
Masters degree and 2 years in Engineering Manufacturing Packaging or Quality experience in pharmaceutical medical device or biotechnology companies.
Or
Bachelors degree and 4 years in Engineering Manufacturing Packaging or Quality experience in pharmaceutical medical device or biotechnology companies.
Or
Associates degree and 8 years in Engineering Manufacturing Packaging or Quality experience in pharmaceutical medical device or biotechnology companies.
Or
High school diploma / GED and 10 years in Engineering Manufacturing Packaging or Quality experience in pharmaceutical medical device or biotechnology companies.
Preferred Qualifications:
- Detailed technical understanding of bioprocessing and manufacturing packaging operations
- Experience with Lean principals (Kaizen Six Sigma Operational Excellence) and knowledge of problemsolving techniques
- Experience in leading crossfunctional teams and managing projects.
- Experience with electronic Quality Management Systems
- Skilled in performance of GMP production operations
- Regulatory knowledge
- Project management skills
- Knowledge of data analysis and control charting
What you can expect from us
As we work to develop treatments that take care of others we also work to care for your professional and personal growth and wellbeing. From our competitive benefits to our collaborative culture well support your journey every step of the way.
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.
In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of 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 that may include:
- A 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 salesbased incentive plan
- Stockbased longterm incentives
- Awardwinning timeoff plans
- Flexible work models including remote and hybrid work arrangements where possible
Apply now and make a lasting impact with the Amgen team.
careers.amgen
In any materials you submit you may redact or remove ageidentifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
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 and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.
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. 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.
.Salary Range
112977.00 USD 139179.00 USDRequired Experience:
Unclear Seniority
Employment Type
Full-Time
