Manager, C&Q Document Preparation (Finished Drug Product / Packaging) Job at Amgen (Hyderabad)

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 Finished Drug Product (FDP), packaging systems, facilities, and utilities qualification activities
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

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

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

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