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Sop Developer Jobs in Raleigh, NC (NOW HIRING)

Sr. Validations Specialist

Morrisville, NC · On-site

$77.20K - $106.20K/yr

Specific responsibilities include reviewing SOP's, composing/revising SOP's and validation master ... Bachelor's Degree in Engineering, Chemistry, Biology, or related field required. * 5+ years of ...

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Sop Developer information

See Raleigh, NC salary details

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How much do sop developer jobs pay per hour?

As of Jun 1, 2026, the average hourly pay for sop developer in Raleigh, NC is $51.36, according to ZipRecruiter salary data. Most workers in this role earn between $39.28 and $62.84 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a SOP Developer, and why are they important?

To thrive as a SOP (Standard Operating Procedure) Developer, you need expertise in process analysis, documentation, and a strong understanding of industry-specific regulations or practices, often supported by relevant work experience or a degree in a related field. Familiarity with documentation tools like Microsoft Word, Visio, or specialized SOP management systems is typically required. Exceptional attention to detail, organizational skills, and the ability to communicate complex processes clearly are essential soft skills. These capabilities ensure the creation of clear, compliant, and actionable SOPs that enhance operational efficiency and consistency.

What are some common challenges faced by SOP Developers when creating and maintaining standard operating procedures?

SOP Developers often encounter challenges such as ensuring that procedures are both comprehensive and easy for team members to follow. Balancing clarity with compliance to regulatory standards can be demanding, especially in highly regulated industries. Additionally, SOP Developers must regularly update procedures to reflect changes in technology, regulations, or organizational processes, which often requires close collaboration with various departments to gather accurate information. Effective communication and adaptability are essential for overcoming these challenges and keeping documentation relevant and user-friendly.

What are SOP Developers?

SOP Developers are professionals responsible for creating, managing, and updating Standard Operating Procedures (SOPs) within an organization. They work closely with subject matter experts to document processes clearly and ensure compliance with industry standards and regulations. Their work helps maintain consistency, improve efficiency, and support training and quality assurance initiatives across various departments.

What is the difference between Sop Developer vs Business Analyst?

AspectSop Developer
Primary RoleDesigning, developing, and maintaining Standard Operating Procedures (SOPs) for organizations
Required SkillsTechnical writing, process analysis, compliance knowledge, documentation skills
Work EnvironmentCorporate, healthcare, manufacturing, or any industry requiring documented procedures
CertificationsOften no formal certifications, but familiarity with industry standards helps

While Sop Developers focus on creating and managing SOP documentation, Business Analysts analyze business processes to recommend improvements. Sop Developers typically work closely with compliance and quality teams, whereas Business Analysts collaborate with stakeholders to optimize workflows. Both roles require strong communication skills, but Sop Developers emphasize technical documentation, while Business Analysts focus on process analysis and solution design.

What are popular job titles related to Sop Developer jobs in Raleigh, NC? For Sop Developer jobs in Raleigh, NC, the most frequently searched job titles are:
What cities near Raleigh, NC are hiring for Sop Developer jobs? Cities near Raleigh, NC with the most Sop Developer job openings:
Infographic showing various Sop Developer job openings in Raleigh, NC as of May 2026, with employment types broken down into 29% Internship, and 71% Full Time. Highlights an 100% In-person job distribution, with an average salary of $106,836 per year, or $51.4 per hour.

Senior Manufacturing Systems Engineer: Automation

Amgen, Inc.

Holly Springs, NC • On-site

$90K - $118.20K/yr

Full-time

Posted 25 days ago


Job description

Career Category
Engineering
Job Description
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's 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, you'll 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 lay within them, you'll 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.
Senior Manufacturing Systems Engineer: Automation
What you will do
Let's do this. Let's change the world. As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations.
In this vital role as a member of the Facilities & Engineering (F&E) Automation team you will work hand in hand with the capital project team to deliver robust process automation systems to operate the new plant. This includes complex and challenging system automation initiatives that require solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecycle management and Operational Excellence.
  • Develop and maintain the process control system on Emerson DeltaV distributed control system (DCS).
  • Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions.
  • Collaborate with business partners to understand how automation can improve workflow and productivity. Synthesize requirements from clients, customers or end-users to develop the best automation solutions.
  • Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity Assessments with the current Amgen and Industry standards.
  • Build the business processes to support the project scope in alignment with project timelines. Develop detailed specification and engineering policies and procedures that affect multiple organizational units.
  • Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.

Ongoing operations:
  • Own and drive to completion Change Controls, CAPAs, and Deviations.
  • Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility.
  • Lead and support technical root cause analysis, incident investigations, and troubleshooting on process control issues related to plant operations.
  • Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable.
  • Handle Day-to-day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Plant and Mfg. Operations, Process and Utility Automaton systems, Preventive and Corrective Maintenance, System Administration, and Automation System spare parts management.
  • 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.

What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with these qualifications.
Basic Qualifications:
  • High School Diploma / GED and 10 years of Engineering experience OR
  • Associate's Degree and 8 years of Engineering experience OR
  • Bachelor's Degree and 4 years of Engineering experience OR
  • Master's Degree and 2 years of Engineering experience OR
  • Doctorate Degree

Preferred Qualifications:
  • Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
  • 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.
  • Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
  • Experience with Emerson DeltaV DCS system, Process Control Network design including network segregation, virtual infrastructure design and implementation, and ability to perform sophisticated troubleshooting activities, system integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies. Experience with DeltaV Live is preferred.
  • 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.
  • Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution.
  • Demonstrated hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.
  • Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g. cycle times, and reduced plant utilities usage etc.) related to Drug Substance Plant Operations.
  • The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.
  • Strong leadership, technical writing, and communication/presentation skills.

What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team!
careers.amgen.com
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.
Salary Range
136,906.95USD -185,227.05 USD