Manager C&Q – Manufacturing Support Job at Amgen (Hyderabad)

Manager, C&Q Document Preparation (Drug Product)

In this vital role, you will lead the preparation and delivery of commissioning ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s or master’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical field
8-13 years of experience in GMP commissioning, qualification, validation, engineering, or technical operations within the pharmaceutical or biotechnology industry
Experience supporting commissioning and qualification activities for manufacturing systems, packaging equipment, or facilities and utilities
Experience preparing or overseeing qualification documentation including protocols, reports, risk assessments, traceability matrices, and testing documentation
Experience working in regulated GMP manufacturing environments with knowledge of inspection readiness and compliance expectations
Strong understanding of GMP commissioning, qualification, and validation practices within regulated pharmaceutical or biotechnology environments
Experience leading technical teams including full-time employees and contingent or outsourced resources
Strong understanding of risk-based qualification methodologies and lifecycle validation approaches
Knowledge of GMP documentation practices, data integrity expectations, and inspection readiness principles
Experience collaborating across Engineering, Validation, Quality, Manufacturing, Facilities, and Project Management teams

Job Responsibility

Lead a team responsible for preparation and delivery of C&Q documentation supporting commissioning and qualification activities across Engineering projects and systems
Manage work across a blended team of employees and contingent resources, ensuring effective planning, prioritization, and execution of deliverables
Oversee development of qualification protocols, reports, risk assessments, traceability matrices, and related qualification documentation
Execute C&Q documentation preparation using established CoE standards, templates, and processes to ensure consistency, compliance, and efficiency
Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams to support qualification execution and operational readiness activities
Monitor documentation progress, identify risks, and drive timely resolution of issues that may impact project timelines
Maintain inspection-ready documentation and support regulatory inspections and internal audits as required
Support implementation of standardized C&Q practices, templates, and procedures across Engineering projects and sites
Provide leadership, coaching, and development for team members while fostering a culture of accountability, collaboration, and quality execution
Contribute to continuous improvement initiatives that enhance C&Q documentation quality, efficiency, and compliance

Fulltime

Manager, C&Q Document Preparation (Finished Drug Product / Packaging)

In this vital role, you will lead the preparation and delivery of commissioning ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in engineering, Life Sciences, Pharmaceutical Sciences, or a related technical field
8-13 years of experience in GMP commissioning, qualification, validation, engineering, or technical operations within the pharmaceutical or biotechnology industry
Experience supporting commissioning and qualification activities for manufacturing systems, packaging equipment, or facilities and utilities
Experience preparing or overseeing qualification documentation including protocols, reports, risk assessments, traceability matrices, and testing documentation
Experience working in regulated GMP manufacturing environments with knowledge of inspection readiness and compliance expectations
Strong understanding of GMP commissioning, qualification, and validation practices within regulated pharmaceutical or biotechnology environments
Experience leading technical teams including full-time employees and contingent or outsourced resources
Strong understanding of risk-based qualification methodologies and lifecycle validation approaches
Knowledge of GMP documentation practices, data integrity expectations, and inspection readiness principles
Experience collaborating across Engineering, Validation, Quality, Manufacturing, Facilities, and Project Management teams

Job Responsibility

Lead a team responsible for preparation and delivery of C&Q documentation supporting commissioning and qualification activities across Engineering projects and systems
Manage work across a blended team of employees and contingent resources, ensuring effective planning, prioritization, and execution of deliverables
Oversee development of qualification protocols, reports, risk assessments, traceability matrices, and related qualification documentation
Execute C&Q documentation preparation using established CoE standards, templates, and processes to ensure consistency, compliance, and efficiency
Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams to support qualification execution and operational readiness activities
Monitor documentation progress, identify risks, and drive timely resolution of issues that may impact project timelines
Maintain inspection-ready documentation and support regulatory inspections and internal audits as required
Support implementation of standardized C&Q practices, templates, and procedures across Engineering projects and sites
Provide leadership, coaching, and development for team members while fostering a culture of accountability, collaboration, and quality execution
Contribute to continuous improvement initiatives that enhance C&Q documentation quality, efficiency, and compliance

Fulltime

Manager, C&Q Document Preparation (Drug Substance)

In this vital role, you will lead the preparation and delivery of commissioning ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical field
8–13 years of experience in GMP commissioning, qualification, validation, engineering, or technical operations within the pharmaceutical or biotechnology industry
Experience supporting commissioning and qualification activities for manufacturing systems, packaging equipment, or facilities and utilities
Experience preparing or overseeing qualification documentation including protocols, reports, risk assessments, traceability matrices, and testing documentation
Experience working in regulated GMP manufacturing environments with knowledge of inspection readiness and compliance expectations

Job Responsibility

Lead a team responsible for preparation and delivery of C&Q documentation supporting commissioning and qualification activities across Engineering projects and systems
Manage work across a blended team of employees and contingent resources, ensuring effective planning, prioritization, and execution of deliverables
Oversee development of qualification protocols, reports, risk assessments, traceability matrices, and related qualification documentation
Execute C&Q documentation preparation using established CoE standards, templates, and processes to ensure consistency, compliance, and efficiency
Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams to support qualification execution and operational readiness activities
Monitor documentation progress, identify risks, and drive timely resolution of issues that may impact project timelines
Maintain inspection-ready documentation and support regulatory inspections and internal audits as required
Support implementation of standardized C&Q practices, templates, and procedures across Engineering projects and sites
Provide leadership, coaching, and development for team members while fostering a culture of accountability, collaboration, and quality execution
Contribute to continuous improvement initiatives that enhance C&Q documentation quality, efficiency, and compliance

Fulltime

Manager, C&Q Document Preparation (Facilities and Utilities)

In this vital role, you will lead the preparation and delivery of commissioning ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical field
8–13 years of experience in GMP commissioning, qualification, validation, engineering, or technical operations within the pharmaceutical or biotechnology industry
Experience supporting commissioning and qualification activities for manufacturing systems, packaging equipment, or facilities and utilities
Experience preparing or overseeing qualification documentation including protocols, reports, risk assessments, traceability matrices, and testing documentation
Experience working in regulated GMP manufacturing environments with knowledge of inspection readiness and compliance expectations
Strong understanding of GMP commissioning, qualification, and validation practices within regulated pharmaceutical or biotechnology environments
Experience leading technical teams including full-time employees and contingent or outsourced resources
Strong understanding of risk-based qualification methodologies and lifecycle validation approaches
Knowledge of GMP documentation practices, data integrity expectations, and inspection readiness principles
Experience collaborating across Engineering, Validation, Quality, Manufacturing, Facilities, and Project Management teams

Job Responsibility

Lead a team responsible for preparation and delivery of C&Q documentation supporting commissioning and qualification activities across Engineering projects and systems
Manage work across a blended team of employees and contingent resources, ensuring effective planning, prioritization, and execution of deliverables
Oversee development of qualification protocols, reports, risk assessments, traceability matrices, and related qualification documentation
Execute C&Q documentation preparation using established CoE standards, templates, and processes to ensure consistency, compliance, and efficiency
Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams to support qualification execution and operational readiness activities
Monitor documentation progress, identify risks, and drive timely resolution of issues that may impact project timelines
Maintain inspection-ready documentation and support regulatory inspections and internal audits as required
Support implementation of standardized C&Q practices, templates, and procedures across Engineering projects and sites
Provide leadership, coaching, and development for team members while fostering a culture of accountability, collaboration, and quality execution
Contribute to continuous improvement initiatives that enhance C&Q documentation quality, efficiency, and compliance

Fulltime

Front Line Manufacturing Manager - Downstream Bulk Drug Substance - Days

Amgen is seeking a Manager Manufacturing Downstream to provide frontline leaders...

Location

United States , Holly Springs

Salary:

106148.00 - 143612.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 3 years of Manufacturing or Operations experience OR Bachelor's degree and 5 years of Manufacturing or Operations experience OR Associate's degree and 10 years of Manufacturing or Operations experience OR High school diploma / GED and 12 years of Manufacturing or Operations experience
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Lead, develop, and coach a manufacturing team
set clear performance expectations
foster a strong culture of safety, quality, and accountability
Support design, build, commissioning, qualification (C&Q), staffing, training, and readiness milestones for a new manufacturing facility
Ensure safe, cGMP-compliant execution
drive performance across safety, quality, schedule, and cost
resolve deviations and operational issues
Support transfer and implementation of manufacturing processes
ensure manufacturability, troubleshooting, and continuous improvement
Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and ramp-up

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

Front Line Manufacturing Manager - Bulk Drug Substance Services - Days

Amgen is seeking a Manager Manufacturing Services to provide frontline leadershi...

Location

United States , Holly Springs

Salary:

106148.00 - 143612.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 3 years of Manufacturing or Operations experience OR Bachelor's degree and 5 years of Manufacturing or Operations experience OR Associate's degree and 10 years of Manufacturing or Operations experience OR High school diploma / GED and 12 years of Manufacturing or Operations experience
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Lead, develop, and coach a manufacturing team
set clear performance expectations
foster a strong culture of safety, quality, and accountability
Support design, build, commissioning, qualification (C&Q), staffing, training, and readiness milestones for a new manufacturing facility
Ensure safe, cGMP-compliant execution
drive performance across safety, quality, schedule, and cost
resolve deviations and operational issues
Support transfer and implementation of manufacturing processes
ensure manufacturability, troubleshooting, and continuous improvement
Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and ramp-up

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

Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days

Let’s do this. Let’s change the world. Amgen is seeking a Manager Manufacturing ...

Location

United States , Holly Springs

Salary:

106148.00 - 143612.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 3 years of Manufacturing or Operations experience OR Bachelor's degree and 5 years of Manufacturing or Operations experience OR Associate's degree and 10 years of Manufacturing or Operations experience OR High school diploma / GED and 12 years of Manufacturing or Operations experience
AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Frontline Leadership: Lead, develop, and coach a manufacturing team
set clear performance expectations
foster a strong culture of safety, quality, and accountability
Facility Startup & Operational Readiness: Support design, build, commissioning, qualification (C&Q), staffing, training, and readiness milestones for a new manufacturing facility
Manufacturing Operations: Ensure safe, cGMP-compliant execution
drive performance across safety, quality, schedule, and cost
resolve deviations and operational issues
Technology Transfer & Process Implementation: Support transfer and implementation of manufacturing processes
ensure manufacturability, troubleshooting, and continuous improvement
Cross-Functional Collaboration: Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and ramp-up

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

Sr. Engineer, ARI Engineering Projects

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

Location

United States , West Greenwich

Salary:

115494.60 - 156257.40 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

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
Degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or related discipline
Experience supporting GMP biopharmaceutical manufacturing operations
Direct knowledge of upstream and/or downstream process equipment including: Bioreactors, Centrifuges, Chromatography systems, UFDF skids, Single-use systems, CIP/SIP systems
Experience with: Commissioning & Qualification (C&Q), Capital project execution, Lifecycle Management Projects, Process troubleshooting, Operational readiness, Manufacturing support
Knowledge of GMP quality systems including: Change controls, Deviations, CAPAs, Risk assessments, Validation documentation
Experience working with DeltaV and process automation systems preferred
Strong technical problem-solving and communication skills
Ability to lead cross-functional initiatives in a fast-paced manufacturing environment
Experience balancing operational support with project execution and continuous improvement initiatives

Job Responsibility

Provide technical expertise in the design and integration of upstream and downstream process equipment
Lead troubleshooting and technical investigations related to process equipment, automation interactions, and operational performance
Support design, construction, startup, commissioning, and qualification of new manufacturing equipment and facility modifications
Review and approve engineering deliverables
Partner with Capital Project teams and Engineering Technical Authorities (ETA) to ensure alignment with Amgen standards and manufacturing requirements
Support utility tie-ins, operational readiness activities, New Product Introductions and hyper care support following startup
Lead and support commissioning and qualification activities for GMP process systems
Identify and implement engineering-based improvements to optimize equipment reliability, throughput, process robustness, and operational efficiency
Lead root cause analysis and implementation of corrective and preventive actions (CAPAs)
Support predictive maintenance, reliability initiatives, and process performance monitoring

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Competitive 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
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

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Manager C&Q – Manufacturing Support

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