- The manager leads 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 CQ documentation practices within the Center of Excellence 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 CQ 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 protocols, reports, risk assessments, traceability matrices, and related qualification documentation

- Execute CQ documentation preparation using establishedCoEstandards, 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

- Monitordocumentation progress,identifyrisks, and drivetimelyresolution of issues that mayimpactproject timelines





- Maintaininspection-ready documentation and support regulatory inspections and internal audits asrequired

- Support implementation of standardized CQ 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 CQ documentation quality, efficiency, and compliance

PREFERRED/GOOD TO HAVE QUALIFICATIONS SKILLS

- Bachelors or Masters degree
- 8-13 Years of work experience in the relevant field
- Experience in GMP commissioning, qualification, validation, or technical operations in a regulated pharmaceutical or biotechnology environment

- Experience preparing or overseeing CQ documentation including qualification protocols, reports, risk assessments, traceability matrices, and testing documentation

- Experience supporting commissioning and qualification activities for manufacturing systems, packaging equipment, or facilities and utilities

- Experience leading technical teams including full time employees and contingent or outsourced resources

- Strong understanding ofrisk-based qualification methodologies and lifecycle validation approaches

- Knowledge ofGMP documentation practices, data integrity expectations, and inspection readiness principles

- Experience collaborating acrossEngineering, 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

📌 Manager - Commissioning & Qualification (C&Q) (Hyderabad)
🏢 Amgen
📍 Hyderabad