Senior Associate Commissioning & Qualification – Manufacturing Support Job at Amgen (Hyderabad)

Senior Associate Manufacturing

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Thousand Oaks

Salary:

86048.05 - 116417.95 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years manufacturing and operations experience OR Associate's + 2 years manufacturing and operations experience OR Bachelor's + 6 months manufacturing and operations experience Master's
Degree in Engineering or Life Sciences
3 years or more experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent
Technical knowledge of drug substance processing and broad understanding of related disciplinary areas
Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
Ability to coach, mentor and/or cross train colleagues within core technical area
Team player - Ability to support process owner team by reprioritizing or readjusting projects, tasks, or responsibilities
Ability to drive results through leadership of cross-functional teams
Experience leading and managing projects
Understanding of single-use technologies

Job Responsibility

Support manufacturing by providing subject-matter expertise for drug substance downstream processes as Single-use SME
Resolve quick issues and implement function tests to troubleshoot and optimize process
Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management
Own Quality Records, such as CCMS, CAPA, and CAPA-EV
Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations
Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance
Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant
Demonstrate strategic problem-solving skills and champion continual improvement
Ability to be on-site (flexible worker)
Support operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills

What we offer

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
Flexible work models where possible

Fulltime

New

Senior Associate Quality Assurance

The Senior Associate QA will be required to perform 12-hour shift (rotational ni...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Masters Degree OR Bachelor's Degree and 2 years of directly related experience OR Associate's Degree and 6 years of directly related experience OR High School Diploma / GED and 8 years of directly related experience
Preferred 5+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical / biologics industry and understanding of GMP pharmaceutical production, biological drug substance experience and operation
Experience with batch record review, and quality record support
Experience in pharmaceutical equipment operation, design and control including GMP change control
Experience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
Understanding of equipment log review and continuous monitoring requirements
Good communication skills (technical writing and verbal communication/presentation)
Interacts effectively with variety of communication and working styles
Experience with regulatory audits and inspections
Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality

Job Responsibility

Conduct Quality Assurance activities related to quality floor support for solution and equipment preparation, cell culture and product purification & Drug Substance Filling operations
Support of electronic batch record review and approval, change control, investigations and product release
Work in a cross functional team with Process Development, Manufacturing, Supply Chain, Engineering and Facilities to ensure product quality and market supply
Role may include participation in new product introductions, additional equipment, installation commissioning, qualification
Support continuous improving initiatives

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Senior Associate C&Q – Drug Substance

Amgen is seeking a Senior Associate specializing in Commissioning & Qualificatio...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in a relevant field (e.g., Computer Science, Engineering or equivalent)
5–9 years of work experience in Information Technology, Information Systems, or a related field
Experience in the global pharmaceutical industry preferred

Job Responsibility

Prepare and revise commissioning and qualification lifecycle documentation supporting Engineering projects and systems
Author qualification protocols, reports, risk assessments, traceability matrices, test scripts, and related C&Q documentation
Support document development activities using approved templates, standards, and CoE procedures
Coordinate technical review cycles and incorporate comments and revisions into final documents
Ensure documentation is accurate, complete, compliant, and inspection-ready
Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams to gather technical information
Track assigned deliverables and support execution against project schedules and milestones
Maintain document organization and version control within applicable quality systems
Support audit and inspection readiness activities as required
Contribute to continuous improvement initiatives focused on documentation quality, consistency, and efficiency

Senior Manufacturing Systems Engineer: Automation

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger...

Location

United States , Holly Springs

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

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 advanced 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

Job Responsibility

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

What we offer

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-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Senior Manufacturing Systems Engineer: Automation (Wednesday - Saturday Shift)

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

136906.95 - 185227.05 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School Diploma / GED and10years of Engineering experience OR Associate's Degreeand8years of Engineering experience OR Bachelor's Degree and4years of Engineering experience OR Master'sDegree and2years of Engineering experience OR DoctorateDegree

Job Responsibility

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

What we offer

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-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Senior Manufacturing Systems Engineer: Automation

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

147421.00 - 177467.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School Diploma / GED and 10 years of Engineering experience
Associate’s Degree and 8 years of Engineering experience
Bachelor’s Degree and 4 years of Engineering experience
Master’s Degree and 2 years of Engineering experience
Doctorate Degree
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
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
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

Job Responsibility

Provide automation technical leadership to a group of automation engineers
Work hand in hand with the capital project team to deliver robust process automation systems to operate the new plant
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

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Senior Manufacturing Systems Engineer

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

147421.00 - 177467.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School diploma/GED and 10 years of engineering experience
Associate’s degree and 8 years of engineering experience
Bachelor’s degree and 4 years of engineering experience
Master’s degree and 2 years of engineering experience
Doctorate degree
Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
Direct knowledge of automation system design
Experience in programming, installation and lifecycle management of automation and field instrumentation technologies
Experience in automation of GMP biopharmaceutical equipment and systems such as buffer prep and hold, chromatography, single use mixing vessels, depth filtration, and solution prep
Experience in integrating various OEM automation software

Job Responsibility

Provide automation technical leadership to a group of automation engineers
Work with the capital project team to deliver robust process automation systems
Support site design, construction, start-up, and operational readiness
Collaborate with key stakeholders and end-users to understand key process requirements and develop solutions
Support design phases to ensure design aligns with specifications
Support vendor FAT to ensure control strategy and software code meet requirements
Develop and maintain engineering and maintenance documentation
Collaborate to develop commissioning and qualification plans
Support commissioning and qualification including Automation Installation Verification/Automation Check Out
Support QA partners in performing computerized systems validation

What we offer

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
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Senior Manufacturing Systems Engineer

Be part of Amgen's newest and most advanced drug substance manufacturing plant. ...

Location

United States , Holly Springs

Salary:

147421.00 - 177467.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High School Diploma / GED and 10 years of Engineering experience
Associate’s Degree and 8 years of Engineering experience
Bachelor’s Degree and 4 years of Engineering experience
Master’s Degree and 2 years of Engineering experience
Doctorate Degree
Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering
Direct knowledge of BAS design, experience in building control engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation and integrating various OEM automation software
Extensive understanding and background in programming, design, installation and lifecycle management of building automation controls, PLC and field device/instrumentation technologies
Experience with Siemens Building Automation system, Rockwell industrial automation hardware and systems, ability to perform sophisticated troubleshooting activities with Amgen DTI, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet 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

Job Responsibility

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
Work hand in hand with the capital project team to deliver robust automation systems to operate the new plant
Maintain the Building Automation System (BAS)on Siemens Desigo CC
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 utility and building equipment systems 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
Maintain detailed specification and engineering policies and procedures that affect multiple organizational units

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

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Senior Associate Commissioning & Qualification – Manufacturing Support

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