CrawlJobs Logo
Amgen Logo Amgen · -

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

India, Hyderabad · Job Posted May 14, 2026
Apply Position
Job Link Share

Job Description

In this vital role, you will lead the preparation and delivery of commissioning and qualification (C&Q) documentation that supports Engineering project execution and GMP manufacturing, packaging, and facility systems across Amgen's operations. The Manager, C&Q Document Preparation will lead a blended team of employees and contingent workers responsible for preparing compliant, inspection-ready documentation that enables successful commissioning, qualification, and operational readiness of Engineering systems and capital projects. This role works closely with Engineering, Automation, Process Development, Validation, Quality, Manufacturing, Facilities, and Project teams to ensure documentation is delivered with high quality and aligned with project timelines. This position plays a key role in executing standardized C&Q documentation practices within the Center of Excellence (CoE) and supporting consistent documentation quality across Engineering projects and sites. This position may support one or more areas including Drug Substance, Drug Product, Finished Drug Product & Packaging, or Facilities & Utilities.

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

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
  • Strong project management and organizational skills with the ability to manage multiple priorities and deadlines
  • Excellent written and verbal communication skills with the ability to translate technical requirements into clear and compliant documentation
  • Experience using standardized templates, processes, and procedures to support consistent C&Q documentation practices
  • Strong leadership and team management skills
  • Effective verbal and written communication skills
  • Ability to collaborate effectively across global cross-functional teams
  • Strong analytical, problem-solving, and decision-making capabilities
  • Strong organizational and time management skills with the ability to manage competing priorities
  • Ability to foster a culture of accountability, collaboration, and quality execution

Nice to have

  • Experience working within a Commissioning & Qualification Center of Excellence (CoE) model
  • Familiarity with facilities, utilities, and infrastructure qualification activities within regulated GMP environments
  • Experience supporting global Engineering capital projects in pharmaceutical or biotechnology environments
  • Exposure to continuous improvement initiatives focused on documentation quality, operational efficiency, and compliance
  • Knowledge of regulatory expectations related to commissioning, qualification, and validation activities

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Similar Jobs for

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

8 matching positions

Manager, C&Q Document Preparation (Drug Product)

In this vital role, you will lead the preparation and delivery of commissioning ...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
Read More
Arrow Right

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

In this vital role, you will lead the preparation and delivery of commissioning ...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
Read More
Arrow Right

Manager, C&Q Document Preparation (Drug Substance)

In this vital role, you will lead the preparation and delivery of commissioning ...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
Read More
Arrow Right

QA C&Q Engineer Pharmaceuticals

We are looking for a CAR‑T QA C&Q Engineer to join the CAR‑T QA Qualification te...
Location
Location
Belgium , Ghent
Salary
Salary:
Not provided
amaris.com Logo
Amaris Consulting
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree in Engineering (with chemistry or analytical background) or in Pharmaceutical Sciences
  • 4–6 years of experience in a GMP‑regulated environment, ideally within biotech, pharma, or advanced therapies (cell/gene therapy is a plus)
  • Solid awareness of quality and strong knowledge of cGMP regulations
  • Understanding of FDA/EU guidance related to manufacturing of cell therapy products
  • Ability and motivation to defend quality strategies and documentation during health authority inspections
  • Affinity with computerized systems and data management in critical production assets: System parameter configuration, Data integrity principles and controls
  • Strong analytical thinking and risk assessment capabilities
  • Excellent communication skills, both written and verbal
  • Proven collaboration and teaming skills
  • able to work cross‑functionally in a dynamic, continuously changing environment
Job Responsibility
Job Responsibility
  • Review and approval of qualification and requalification activities related to Facilities & Utilities (F&U) and Process Equipment at the CAR‑T manufacturing facilities
  • Work closely with Make Asset Management (MAM) and Engineering & Property Services (E&PS) to guard the qualification status of critical production assets
  • Ensure all system critical aspects related to facilities & utilities, product, and process requirements are identified, qualified, and controlled via appropriate mitigation plans
  • Ensure deviations related to equipment issues with potential impact on quality and/or compliance are evaluated, thoroughly investigated, and that adequate corrective and/or preventive actions (CAPA) are defined and implemented
  • Collaborate with the manufacturing department to review and approve new change controls
  • Ensure deviations with potential impact on quality and/or compliance are evaluated, investigated, and addressed with appropriate CAPAs
  • Build strong connections with different quality organizations and stakeholders
  • Manage the compliance status of critical production assets by reviewing and approving procedures
  • Overseeing master data set‑up, maintenance plans, and daily operations activities
  • Reviewing and approving data integrity deliverables such as system audit trail and user access reviews
What we offer
What we offer
  • Rapid growth opportunities
  • Prestigious projects with renowned clients
  • International environment
  • Fulltime
Read More
Arrow Right

Continuous Improvement Lead – Commissioning & Qualification

Amgen is seeking a Continuous Improvement Lead – Commissioning & Qualification (...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelors or Masters degree
  • 8-13 Years of work experience in the relevant field
  • Experience implementing or supporting digital transformation initiatives within Engineering, Validation, or Technical Operations environments
  • Knowledge of ASTM E2500, ISPE guidance, or modern risk-based commissioning and qualification approaches
  • Experience driving cross-site or global process standardization initiatives
  • Experience in GMP commissioning, qualification, validation, or technical operations in a regulated pharmaceutical or biotechnology environment
  • Experience implementing or supporting Kneat or other electronic validation / digital documentation platforms
  • Experience leading continuous improvement, digital enablement, or process standardization initiatives across engineering or technical operations programs
  • Experience developing metrics, dashboards, or reporting tools using PowerBI, Tableau, Smartsheet, or similar analytics platforms
  • Strong understanding of risk-based qualification methodologies and lifecycle validation approaches
Job Responsibility
Job Responsibility
  • Lead continuous improvement initiatives focused on C&Q document preparation, digital C&Q execution, and process standardization
  • Establish and maintain governance for C&Q digital tools, documentation standards, and continuous improvement initiatives across Engineering projects and sites
  • Drive optimization, governance, and adoption of Kneat and other digital validation tools across Engineering projects and manufacturing sites
  • Develop and maintain standardized templates, workflows, and best practices supporting digital commissioning and qualification execution
  • Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Digital Technology teams to identify and implement process and technology improvements
  • Establish and monitor performance metrics and reporting to measure efficiency, documentation quality, and program effectiveness
  • Analyze operational data and program metrics to identify opportunities to improve efficiency, compliance, and execution consistency
  • Lead implementation and adoption of standardized C&Q practices, templates, and procedures across Engineering projects and sites
  • Provide training, coaching, and user support for Kneat and other digital tools used in C&Q execution
  • Ensure digital processes and documentation practices align with GMP requirements, data integrity standards, and regulatory expectations
Read More
Arrow Right

Job Maps Management Specialist

Location
Location
Poland , Wrocław
Salary
Salary:
Not provided
amrest.eu Logo
AmRest
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum 1 years’ experience in a similar position
  • Communicative level of English
  • Excellent knowledge of MS Office
  • Diligence and attention to details
  • Ability to plan and manage work
  • Experience in working in an international environment.
Job Responsibility
Job Responsibility
  • Manage and maintain global Job Descriptions and Job Maps, ensuring accuracy, consistency, and alignment with the organization’s structure and business model
  • Apply and support global job mapping standards and methodology across brands, functions, and countries
  • Act as a partner and subject‑matter expert for HR teams and business stakeholders regarding Job Maps, role scopes, and job titles
  • Ensure alignment between Job Maps and the Global Job Titles Matrix, providing guidance on correct job title usage
  • Monitor the quality, completeness, and adoption of Job Maps
  • Maintain Job Descriptions and position data in HR systems (e.g. SyncPeople), ensuring data accuracy and regular updates
  • Support job architecture projects and rollouts and contribute to related communication and training materials.
What we offer
What we offer
  • Stable employment under an employment contract in a global organization
  • Annual bonus - up to 10% of gross annual earnings
  • Work in a hybrid / remote model
  • Personalized benefits package: discounts to our cafes and restaurants, private medical care, Multisport card and much more
  • A friendly atmosphere in an international and fast growing Team.
  • Fulltime
Read More
Arrow Right

Front Desk Coordinator

Front Desk Coordinator Are you an organized detail oriented with excellent commu...
Location
Location
United States of America , Saint Louis
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Previous experience in a receptionist or administrative support role preferred
  • Strong communication and customer service skills
  • Ability to multitask and prioritize in a fast-paced environment
  • Proficiency with office technology and Microsoft Office Suite
Job Responsibility
Job Responsibility
  • Greet visitors, clients, and team members with professionalism and warmth
  • Answer and route incoming calls
  • manage messages and inquiries
  • Maintain reception area and conference room schedules
  • Handle mail, deliveries, and office supply inventory
  • Assist with administrative tasks, data entry, and special projects
  • Collaborate with staff to support internal communication and workflow
What we offer
What we offer
  • Competitive compensation and benefits
  • Collaborative, welcoming work culture
  • Opportunities for skill development and career growth
  • Exposure to multiple departments and business operations
  • Medical, vision, dental, and life and disability insurance
  • 401(k) plan
  • Fulltime
Read More
Arrow Right

Sales and Customer Service Representative

A growing mid-size organization is seeking a results-driven Sales & Customer Ser...
Location
Location
United States of America , Morristown
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 1–3+ years of experience in sales, inside sales, or a sales-driven customer service role
  • Proven ability to meet or exceed sales targets
  • Strong communication and negotiation skills
  • Highly motivated, competitive, and results-oriented
  • Proficiency in Microsoft Office
  • CRM experience (Salesforce, HubSpot, etc.) preferred
  • Ability to multitask in a fast-paced, team-oriented environment
Job Responsibility
Job Responsibility
  • Proactively engage with prospective and existing customers to generate sales and meet revenue targets
  • Identify upsell and cross-sell opportunities to grow account value
  • Manage the full sales cycle, from initial outreach through order placement and follow-up
  • Build and maintain strong client relationships to drive repeat business and long-term partnerships
  • Handle customer inquiries, resolve issues, and ensure a positive customer experience
  • Process orders, prepare quotes, and provide product or service recommendations
  • Maintain accurate records of sales activity, pipeline, and client interactions within CRM systems
  • Track performance against sales goals and report on activity and results
What we offer
What we offer
  • medical
  • vision
  • dental
  • life and disability insurance
  • 401(k) plan
  • free online training
Read More
Arrow Right