Manager, Commissioning & Qualification (C&Q) Document Preparation - Facilit at Amigen

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

09 Jul, 26

Salary

0.0

Posted On

10 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Commissioning, Qualification, Validation, GMP, Project Management, Risk Assessment, Traceability Matrices, Technical Operations, Biotechnology, Pharmaceutical, Data Integrity, Inspection Readiness, Engineering, Automation, Quality Assurance, Operational Readiness

Industry

Biotechnology Research

Description

Career Category Engineering Job Description ABOUT THE ROLE Amgen is seeking a Manager, Commissioning & Qualification (C&Q) Document Preparation to join the Engineering Commissioning & Qualification (C&Q) Center of Excellence (CoE). In this role, you will lead the preparation and delivery of commissioning and qualification documentation that supports Engineering project execution and GMP manufacturing, packaging, and facility systems across Amgen’s operations. 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 C&Q 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 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 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 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 C&Q 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 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 . 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

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Responsibilities

Lead a team in the preparation and delivery of compliant commissioning and qualification documentation for engineering projects and GMP systems. Collaborate with cross-functional teams to ensure documentation quality, project alignment, and operational readiness.