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Specialist Manufacturing - Inspection & Packaging

Specialist Manufacturing - Inspection & Packaging
Empresa:

Amgen


Lugar:

Juncos

Detalles de la oferta

Career Category
Manufacturing
Job Description

Are you looking for a meaningful new opportunity to test and growth your technical skills? We have an immediate need for various Specialist Manufacturing to join AML’s Inspection & Packaging a Non Standard Shift Organization. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.

The Role

The Specialist Manufacturing role supports the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
Applied Process Expertise
Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
Provide troubleshooting support.
Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
Ensures that processes, and procedures are aligned with cGMP requirements and/or other applicable regulations
Responsible for ensuring that risks are identified, assessed and corrected to ensure the safety, purity, quality, and efficiency of the product(s) manufactured
Responsible for ensuring that the Electronic Batch Record is aligned with the current process and may assist in providing training.
Continuous process monitoring to implement process improvement
Process Monitoring
Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
Provide support of timely execution of the process monitoring quarterly reports.
Deviations and CAPA
Ensure that all non-conformance investigation are triaged within the established goal.
Responsible for authoring investigation reports.
Responsible for implementation of corrective actions.
Responsible for leading Deviation /CAPA closure within established goal.
Monitor and communicate incidents trends.
Review equipment/system Root Cause Analysis investigations and support trend evaluations.
Own non-conformance investigations, and ensure that corrective actions and preventive actions (CAPA) implemented are effective.
Process Validation
Assist with generation of process validation protocols and reports.
Assist with the implementation of the process validation.
Support collection and analysis of process validation data.
Regulatory
Participate in regulatory inspections.
New Product Introductions & Process or Equipment Modifications
Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
Assess, prioritize, support, and provide implementation and project management support for process or equipment modification projects.
Own Change Control and ensure implementation within established goal.
Change Control
Assist manufacturing change owner on CCRB packages impacting the process.
Own Change Control and ensure implementation within established goal.
Participate in noncommercial activity runs to support the collection and analysis of process data.
Projects and Initiatives
Participate on the assessment or implementation of special projects or initiatives.
Basic Education & Experience
Doctorate degree

or

Master’s degree and 3 years of experience in Pharmaceutical, Medical Device or Biotechnology Industry.

or
Bachelor’s degree and 5 years of experience in Pharmaceutical, Medical Device or Biotechnology Industry.

Preferred qualifications
Educational background in Life Sciences or Engineering
Detailed technical understanding of bio processing unit operations.
Good Documentation practices
Verbal and written communication in English and Spanish
Skilled in performance of GMP production operations
Regulatory knowledge and interactions
Participate and help lead cross-functional teams
Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
Organizational, technical writing and presentation skills.
Basic project management skills.
Basic knowledge of control charting
The benefits
Our broad approach is one of the reasons why we are regularly recognized as a ‘Best Place To Work’. We offer an outstanding benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program – and on-site child care and fitness facilities – you will find us passionate about your well-being too.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.
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, or disability status.

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Fuente: Simplyhired

Requisitos


Conocimientos:
Specialist Manufacturing - Inspection & Packaging
Empresa:

Amgen


Lugar:

Juncos

Built at: 2024-03-29T01:26:09.855Z