BioSpace
Sr. Engineer - Process Development (Commissioning, Qualification, and Validatio
BioSpace, New Albany, Ohio, United States, 43054
Overview
Sr. Engineer - Process Development (Commissioning, Qualification, and Validation) role at Amgen. The position supports commercial GMP Final Drug Product (FDP) operations at the Amgen Ohio facility. What You Will Do
The Senior Engineer reports to the Sr. Manager of Validation. This role applies diverse and advanced engineering and scientific principles to support FDP operations at the Amgen Ohio facility. Functions
Support the development and implementation of automated and semi-automated device assembly equipment initiatives as part of the Finished Drug Product (FDP) portfolio at the Amgen Ohio site. Lead qualification and validation efforts for combination products and related processes, applying advanced engineering principles across process, unit operations, equipment, devices and materials for complex process optimization. Outputs
Project Management
- Support Qualification and Validation of the Amgen product portfolio to AOH. Provide technical operations support for continuous improvement of device assembly and packaging line capacity and performance, and advise on technical improvement projects. Ensure effective communication with stakeholders across the Amgen Ohio site and network. Technical Lead
- Act as site technical expert for automated/semi-automated device assembly for FDP and non-combination products. Serve as the technical lead for new process and existing device assembly technology. Resolve process challenges with appropriate expertise; experience in combination product assembly is required. Operational Excellence
- Support productivity, throughput, and capacity improvements by analyzing and implementing manufacturing and business process improvements at the AOH site. What We Expect Of You
We seek a CQV professional with the following qualifications and mindset. Basic Qualifications
Doctorate degree OR Master’s degree and 2 years in a GMP regulated environment OR Bachelor’s degree and 4 years in a GMP regulated environment OR Associate’s degree and 8 years in a GMP regulated environment OR High school diploma / GED and 10 years in a GMP regulated environment Preferred Qualifications
Knowledge of combination product assembly equipment and applicable testing Excellent written and verbal communication skills with ability to work in a team environment Proven track record of leading and executing cross-functional projects Strong teamwork, interpersonal and communication skills Direct experience with the manufacturing process for devices, combination products and label & packaging operations Experience with Final Drug Product equipment suppliers Ability to work in a highly regulated and changing industry Ability to learn and adapt to new requirements in a fast-moving environment Operational Excellence approach to drive rapid results and develop others with a positive attitude What you can expect from us
Competitive benefits and a collaborative culture supporting your professional and personal growth. Salaries vary based on skills and experience. Amgen offers a Total Rewards Plan including health and welfare plans, retirement savings, work/life balance, and career development opportunities. Equal Opportunity
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. Reasonable accommodations are available to applicants with disabilities for the interview process and to perform essential job functions. For accommodation requests, please contact Amgen.
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Sr. Engineer - Process Development (Commissioning, Qualification, and Validation) role at Amgen. The position supports commercial GMP Final Drug Product (FDP) operations at the Amgen Ohio facility. What You Will Do
The Senior Engineer reports to the Sr. Manager of Validation. This role applies diverse and advanced engineering and scientific principles to support FDP operations at the Amgen Ohio facility. Functions
Support the development and implementation of automated and semi-automated device assembly equipment initiatives as part of the Finished Drug Product (FDP) portfolio at the Amgen Ohio site. Lead qualification and validation efforts for combination products and related processes, applying advanced engineering principles across process, unit operations, equipment, devices and materials for complex process optimization. Outputs
Project Management
- Support Qualification and Validation of the Amgen product portfolio to AOH. Provide technical operations support for continuous improvement of device assembly and packaging line capacity and performance, and advise on technical improvement projects. Ensure effective communication with stakeholders across the Amgen Ohio site and network. Technical Lead
- Act as site technical expert for automated/semi-automated device assembly for FDP and non-combination products. Serve as the technical lead for new process and existing device assembly technology. Resolve process challenges with appropriate expertise; experience in combination product assembly is required. Operational Excellence
- Support productivity, throughput, and capacity improvements by analyzing and implementing manufacturing and business process improvements at the AOH site. What We Expect Of You
We seek a CQV professional with the following qualifications and mindset. Basic Qualifications
Doctorate degree OR Master’s degree and 2 years in a GMP regulated environment OR Bachelor’s degree and 4 years in a GMP regulated environment OR Associate’s degree and 8 years in a GMP regulated environment OR High school diploma / GED and 10 years in a GMP regulated environment Preferred Qualifications
Knowledge of combination product assembly equipment and applicable testing Excellent written and verbal communication skills with ability to work in a team environment Proven track record of leading and executing cross-functional projects Strong teamwork, interpersonal and communication skills Direct experience with the manufacturing process for devices, combination products and label & packaging operations Experience with Final Drug Product equipment suppliers Ability to work in a highly regulated and changing industry Ability to learn and adapt to new requirements in a fast-moving environment Operational Excellence approach to drive rapid results and develop others with a positive attitude What you can expect from us
Competitive benefits and a collaborative culture supporting your professional and personal growth. Salaries vary based on skills and experience. Amgen offers a Total Rewards Plan including health and welfare plans, retirement savings, work/life balance, and career development opportunities. Equal Opportunity
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. Reasonable accommodations are available to applicants with disabilities for the interview process and to perform essential job functions. For accommodation requests, please contact Amgen.
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