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

Amgen; Hyderabad; On-site; INR 2,400,000 - 3,600,000; Full time

Job summary

Amgen Inc. (IR) is seeking a Manager of C&Q Document Preparation to lead the creation and delivery of commissioning and qualification documentation across Engineering projects.

You will oversee a blended team of employees and contingent staff to ensure compliant, inspection-ready materials. You will collaborate with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams to drive timely qualification execution and operational readiness, while promoting standardized

Qualifications

• Strong understanding of GMP commissioning, qualification and validation in regulated environments.
• Experience leading technical teams including FTEs and contingent resources.
• Knowledge of risk-based qualification methodologies and lifecycle validation approaches.
• Familiarity with GMP documentation practices, data integrity and inspection readiness.

Responsibilities

• Lead a team responsible for preparation and delivery of C&Q documentation for commissioning and qualification activities.
• Manage work across a blended team of employees and contingent resources, ensuring planning and execution of deliverables.
• Oversee development of qualification protocols, reports, risk assessments, traceability matrices, and related documents.
• Execute C&Q documentation using established CoE standards, templates, and processes for consistency and compliance.
• Collaborate with Engineering, Validation, Quality, Manufacturing, Facilities, and Project teams to support qualification execution.
• Monitor progress, identify risks, and drive timely resolution to avoid project delays.
• Maintain inspection-ready documentation and support regulatory inspections and internal audits.
• Support standardization of C&Q practices, templates, and procedures across sites.
• Provide leadership, coaching, and development for team members, fostering accountability and quality.
• Contribute to continuous improvement to enhance documentation quality and efficiency.

Skills

GMP knowledge

Team leadership

Risk-based qualification

Documentation standards

Education

Bachelor’s or Master’s degree in Engineering/Life Sciences/Pharmaceuticals

Job description

Career Category Engineering Job Description

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting‑edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role 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.

Roles & Responsibilities

• 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.

Basic Qualifications and Experience

• 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.

Functional Skills (Must Have)

• 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.

Good‑to‑Have Skills

• 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.

Soft Skills

• 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.

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with 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.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen