Manufacturing Systems Engineer: Automation
BioSpace · Holly Springs, NC · 2 wk ago
EngineeringFull-time
We need to output HTML fragment with sections: About the role? Actually the posting includes mission description, then details about role. We need headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. Must not include Job ID etc. Must remove boilerplate. Must preserve all substantive info.
We need to parse content.
The posting:
- Intro: "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 award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lie within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027."
That's about the role/company. Could be "About the role" or maybe "About Amgen". The instruction: use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have "About the role" heading.
Then "Manufacturing Systems Engineer: Automation What you will do Lets do this. Lets change the world. As a Manufacturing Systems Engineer, you will work with a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP DrugSubstancePlant Operations. In this vital roleas a member of the Facilities & Engineering (F&E) Automation teamyou will work hand in hand with the capital project team to deliver robust process automation systems to operate the new plant."
That's more description; could be part of About the role.
Then "Responsibilities" heading with bullet list.
Responsibilities list:
- Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS).
- Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems.
- Provide clear documentation for delivered solutions and processes.
- Support QA partners in performing computerized systems validation in a GxP environment.
- Perform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards.
- Support process automation systems to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements.
- Support vendor FAT to ensure that control strategy and software code meet Amgen requirements.
- Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes.
- Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.
- Site Operations Own and drive to completion Change Controls, CAPAs, and Deviations.
- Support technical root cause analysis, incident investigations, and troubleshooting.
- Support functional area projects focused on improving process equipment, utilities, and facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility.
- Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability.
- Support day-to-day operations including rotational on-call support.
- Prepare/review Standard Operating Procedures (SOP) and cGMP documents.
- Be constantly curious and feed your passion and interests in groundbreaking technology.
- Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively.
That's a list.
Then "What we expect from you" heading with qualifications.
We need to map to Requirements, Qualifications, Skills sections. The posting has "Basic Qualifications" and "Preferred Qualifications". Also "What you can expect from us" includes benefits.
We need to decide sections: Could have "Requirements" for basic qualifications, "Qualifications" for preferred qualifications, "Skills" maybe for technical skills? But we should not create thin sections. We can combine.
We have "Basic Qualifications": list of education/experience combos.
"Preferred Qualifications": degree in specific fields, direct knowledge of automation system design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors, solution prep, single use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integrating various OEM automation software. Experience in programming, installation, and lifecycle management of automation and field instrumentation technologies. Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies. Experience with Emerson DeltaV DCS system and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies. Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95. Self-directed team player able to work cross-functionally. Strong technical writing and communication skills.
That's a lot; could be under "Qualifications" or "Skills". The instruction: Use headings like Requirements, Qualifications, Skills. We can put basic qualifications under "Requirements", preferred qualifications under "Qualifications", and maybe skills under "Skills" but we might not need separate Skills if content overlaps. However we have technical skills listed in preferred qualifications; we could put them under "Skills". But we must not create empty sections.
We also have "What you can expect from us" describing benefits: total rewards plan, base salary, etc. That's benefits. So we can have Benefits section.
Pay: The posting mentions base salary but not specific amount; says "In addition to the base salary, Amgen offers a Total Rewards Plan based on eligibility that may include: ..." It does not give a number. The instruction: never create Pay/Schedule/Benefits sections unless the posting actually states them. It does mention base salary but not a specific figure; still it's stating that there is a base salary. Is that enough to include Pay section? The instruction says "never create Pay/Schedule/Benefits sections unless the posting actually states them." It does state base salary (though not amount). Likely we can include Pay section with mention of base salary and total rewards. However we also have Benefits section describing the total rewards. Could combine Pay and Benefits? But they are separate headings suggested. We could have Benefits section describing the total rewards, and Pay section maybe just note base salary (unspecified). But that might be thin. Better to combine into Benefits and omit Pay if not specific. The instruction: Prefer a few substantive sections over many thin ones. So we could have Benefits section covering total rewards, and not separate Pay.
Schedule: Not mentioned. So omit Schedule.
Thus sections: About the role, Responsibilities, Requirements (basic qualifications), Qualifications (preferred qualifications), Benefits.
We could also include Skills if we want to separate technical skills, but we can incorporate them into Qualifications.
We must not repeat job title as heading. The job title is "Manufacturing Systems Engineer: Automation". We must not use that as heading.
Now produce HTML fragment:
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have "About the role" heading.
Then "Manufacturing Systems Engineer: Automation What you will do Lets do this. Lets change the world. As a Manufacturing Systems Engineer, you will work with a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP DrugSubstancePlant Operations. In this vital roleas a member of the Facilities & Engineering (F&E) Automation teamyou will work hand in hand with the capital project team to deliver robust process automation systems to operate the new plant."
That's more description; could be part of About the role.
Then "Responsibilities" heading with bullet list.
Responsibilities list:
- Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS).
- Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems.
- Provide clear documentation for delivered solutions and processes.
- Support QA partners in performing computerized systems validation in a GxP environment.
- Perform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards.
- Support process automation systems to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements.
- Support vendor FAT to ensure that control strategy and software code meet Amgen requirements.
- Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes.
- Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.
- Site Operations Own and drive to completion Change Controls, CAPAs, and Deviations.
- Support technical root cause analysis, incident investigations, and troubleshooting.
- Support functional area projects focused on improving process equipment, utilities, and facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility.
- Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability.
- Support day-to-day operations including rotational on-call support.
- Prepare/review Standard Operating Procedures (SOP) and cGMP documents.
- Be constantly curious and feed your passion and interests in groundbreaking technology.
- Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively.
That's a list.
Then "What we expect from you" heading with qualifications.
We need to map to Requirements, Qualifications, Skills sections. The posting has "Basic Qualifications" and "Preferred Qualifications". Also "What you can expect from us" includes benefits.
We need to decide sections: Could have "Requirements" for basic qualifications, "Qualifications" for preferred qualifications, "Skills" maybe for technical skills? But we should not create thin sections. We can combine.
We have "Basic Qualifications": list of education/experience combos.
"Preferred Qualifications": degree in specific fields, direct knowledge of automation system design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors, solution prep, single use mixing vessels, chromatography, TFFL/TFFX, viral filtration, viral inactivation, UF/DF, depth filtration, drug substance fill, CIP/SIP, clean utilities, and integrating various OEM automation software. Experience in programming, installation, and lifecycle management of automation and field instrumentation technologies. Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies. Experience with Emerson DeltaV DCS system and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies. Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95. Self-directed team player able to work cross-functionally. Strong technical writing and communication skills.
That's a lot; could be under "Qualifications" or "Skills". The instruction: Use headings like Requirements, Qualifications, Skills. We can put basic qualifications under "Requirements", preferred qualifications under "Qualifications", and maybe skills under "Skills" but we might not need separate Skills if content overlaps. However we have technical skills listed in preferred qualifications; we could put them under "Skills". But we must not create empty sections.
We also have "What you can expect from us" describing benefits: total rewards plan, base salary, etc. That's benefits. So we can have Benefits section.
Pay: The posting mentions base salary but not specific amount; says "In addition to the base salary, Amgen offers a Total Rewards Plan based on eligibility that may include: ..." It does not give a number. The instruction: never create Pay/Schedule/Benefits sections unless the posting actually states them. It does mention base salary but not a specific figure; still it's stating that there is a base salary. Is that enough to include Pay section? The instruction says "never create Pay/Schedule/Benefits sections unless the posting actually states them." It does state base salary (though not amount). Likely we can include Pay section with mention of base salary and total rewards. However we also have Benefits section describing the total rewards. Could combine Pay and Benefits? But they are separate headings suggested. We could have Benefits section describing the total rewards, and Pay section maybe just note base salary (unspecified). But that might be thin. Better to combine into Benefits and omit Pay if not specific. The instruction: Prefer a few substantive sections over many thin ones. So we could have Benefits section covering total rewards, and not separate Pay.
Schedule: Not mentioned. So omit Schedule.
Thus sections: About the role, Responsibilities, Requirements (basic qualifications), Qualifications (preferred qualifications), Benefits.
We could also include Skills if we want to separate technical skills, but we can incorporate them into Qualifications.
We must not repeat job title as heading. The job title is "Manufacturing Systems Engineer: Automation". We must not use that as heading.
Now produce HTML fragment:
About the role
... (the mission/intro paragraph(s) )
ThenResponsibilities
- ... each responsibility
Requirements
Basic Qualifications: ... list combos.
Could also use- for each combo.
Then
- .
Now Requirements: Basic Qualifications: "High School Diploma / GED and 8 years of Engineering experience OR Associates Degree and 6 years of Engineering experience OR Bachelors Degree and 2 years of Engineering experience OR Masters Degree". We'll put as
- ... OR ...
- . Now Benefits: "What you can expect from 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. From our competitive benefits to our collaborative culture, well support your journey every step of the way. In addition to the base salary, Amgen offers a Total Rewards Plan based on eligibility 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 sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company
Qualifications
Preferred Qualifications: ... list.
Could use- .
Then
Benefits
What you can expect from us: ... total rewards plan details.
Could use- .
Make sure to preserve all substantive info. Remove boilerplate like "Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine and the last to doubt. Join us. careers.amgen.com #AmgenNorthCarolina". Also remove cookie/navigation/legal/EEO etc. There's none visible.
We must not include duplicated lines.
Let's craft.
First, About the role paragraph: combine the mission description and facility description.
We need to keep all substantive info: mention mission, four therapeutic areas, award-winning culture, passion for challenges, transform lives, newest drug substance manufacturing plant, FleX Batch facility details: disposable tech + stainless steel, max flexibility, best-in-class drug substance manufacturing tech with embedded industry 4.0, sustainability innovations to reduce carbon and waste, part of plan to be carbon-neutral by 2027.
We'll put that in
. Now Responsibilities list: each bullet as