Continuous Improvement Lead – Commissioning & Qualification Job at Amgen (Hyderabad)

Head of Commissioning

We’re looking for a Head of Commissioning to ensure a strong, stable business-as...

Location

United Kingdom , Surrey

Salary:

Not provided

Myn

Expiration Date

Until further notice

Requirements

Degree or equivalent professional qualification, with management‑level experience in a complex environment
Extensive knowledge of change management, project management and continuous improvement
Strong understanding of commissioning practice, processes and sector‑wide context
Ability to balance policy development with operational delivery
Advanced leadership skills, with the ability to inspire, motivate, coach and develop teams
Excellent written and verbal communication, interpersonal, negotiation and influencing skills
Ability to work collaboratively with internal and external partners
Deep understanding of relevant legislation, practice standards and national service‑delivery context
Evidence of ongoing professional development, including leadership and management training
Proven experience leading successful teams in a commissioning environment

Job Responsibility

Lead the implementation of the Dynamic Purchasing System (DPS) for providers supporting people with learning disabilities, autism and mental health needs
Act as the single, trusted point of contact for providers and elected members, ensuring clarity and confidence in commissioning arrangements
Maintain strong provider relationships and ensure providers remain engaged throughout the transformation
Oversee completion and embedding of the new Support in the Community tender
Embed care‑technology commissioning approaches across the service to support a sustainable care‑tech strategy for future councils
Ensure commissioning activity aligns with political, strategic and financial priorities
Maintain practice standards, customer service, quality assurance, performance and contract management across commissioning services
Lead service improvement, transformation and commercial awareness across directorates
Build and lead cross‑functional teams (Procurement, Legal, Finance, Contracts, Business Analysis) through direct and matrix management
Develop and manage markets to meet current and future service needs

Plant Process Engineer

We are currently seeking an experienced Plant Process Engineer to support manufa...

Location

Switzerland , Neuchâtel

Salary:

80.00 - 85.00 CHF / Hour

CK Group

Expiration Date

Until further notice

Requirements

Engineering degree (BSc, MSc, or equivalent) in Biotechnology, Chemistry, Food Processing, or Mechanical Engineering
7+ years’ experience in Pharma/Biotech (Process Engineering, Plant Engineering, or Manufacturing)
Strong experience with installation, commissioning, and validation of pharmaceutical process equipment
Experience with automation systems (Siemens and/or Allen Bradley) is a strong advantage
Maintenance and utilities experience is considered an asset
Strong knowledge of GEP, cGxP, FDA, ISPE, ASTM 2500, ASME BPE standards
Fluent in English and French (spoken and written)
Strong problem-solving and technical learning capability
Team-oriented, action-driven, and comfortable in a hands-on, fast-paced environment
Proficient with MS Office and MS Project

Job Responsibility

Act as primary technical SME for assigned production equipment and systems
Provide engineering support for investigations, recurring issues, modifications, and continuous improvement initiatives
Lead and/or support design, installation, commissioning, and qualification activities
Ensure equipment and systems remain fit for use
proactively identify risks and improvement opportunities
Coordinate and organise corrective actions, modifications, and upgrades
Ensure compliance with cGMP, GEP, SUVA/ASIT, and internal engineering standards
Support site and cross-functional projects of varying complexity
Participate as system expert in internal and external audits
Ensure all activities meet health, safety, and environmental requirements

What we offer

Competitive CHF 80–85/hour contract rate
12-month contract with potential extension
High-impact role within a regulated, cutting-edge biotech facility
Dynamic, collaborative engineering environment

Fulltime

Senior Manager Manufacturing (API)

The scope includes leading a team of professionals to provide validation service...

Location

Singapore , Tuas

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree in Science or Engineering and 2 years of directly related experience
Master’s degree in Science or Engineering and 6 years of directly related years’ experience
Bachelor’s degree in Science or Engineering and/or 8 years of directly related experience
2 years of managerial experience directly managing people and / or leadership experience leading teams, projects, programs or directing the allocation of resource
8+ years’ experience in support of commercial drug operations (manufacturing, quality, process development, clinical mfg, engineering)
5+ years managing a team (leading and managing operations)
2+ years project management (identify goals, manage resources, assign tasks, present progress/milestones, develop cost/benefit analysis and negotiate resolution)
2+ years operations and/or technical experience in the pharmaceutical industry
managing process improvement through Operational Excellence, depth in one operations area (information systems, manufacturing, quality, process development, engineering, etc.)
Ability to understand, apply and evaluate advanced chemistry, biology and physical principles

Job Responsibility

Establish compliant validation strategies and procedures to align with Amgen operating standards and regulatory expectations
Accountable for completing milestones as they relate to validation deliverables for commissioning and qualification, performance qualifications, cleaning validation, and validation maintenance
Ensure that all staff working on validation are adequately trained and skilled to perform their duties
Provide technical support to troubleshoot, identify and resolve equipment and system issues as required
Own and lead investigations associated with validation or process deviations and non-conformances
Manage change controls, corrective actions and preventative actions associated with validation or process equipment
Deliver results in accordance with cGMP and safety requirements.
Be part of ASM 2 leadership to advocate and drive safety and quality culture of the department and lead continued improvements within the areas of scope.
Champions cultural transformation and institutionalizes changes in process, practices, business models, governance, etc.
Anticipates risk and builds contingencies to help mitigate impact on operations

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

New

Manager, Commissioning & Qualification (C&Q) Document Preparation - Drug Substance

Amgen is seeking a Manager, Commissioning & Qualification (C&Q) Document Prepara...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

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

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 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

New

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

Amgen is seeking a Manager, Commissioning & Qualification (C&Q) Document Prepara...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

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

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 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

New

Director - Site Validation

At Amgen, our mission is to serve patients. At our Dun Laoghaire (ADL) site, we ...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of directly relevant experience
Master’s degree and 8 years of directly related experience
Bachelor’s degree in Engineering, Life Sciences, or associated discipline and 10 years of directly related experience
Within experience must have 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources
Extensive experience in validation within a sterile/aseptic manufacturing environment (fill-finish highly preferred)
Strong expertise in: Aseptic process simulation (media fills)
Cleaning validation
Equipment qualification and lifecycle management
Commissioning and qualification (CQV) for capital projects
Proven experience supporting large-scale capital project delivery and facility start-ups

Job Responsibility

Strategic leadership for all site validation activities, ensuring alignment with Amgen global standards, regulatory requirements, and site objectives
Leading and developing a high-performing Validation organisation, setting clear expectations and fostering a culture of quality, compliance, accountability, and continuous improvement
Development of the organisation includes robust succession planning as well as a focus on how the function will support 24/7 operations e.g. via a new validation shift team
Owning all validation lifecycle activities including: Aseptic Process Simulations (media fills) strategy and execution
Airflow Visualisation Studies (AVS) and HVAC requalification programs
Sterilisation validation (VHP, autoclaves, SIP/CIP, lyophilisation)
Cleaning validation programs
Equipment validation
Facilities and Utilities
Effective continued process verification and lifecycle validation, including periodic review, requalification and data-driven performance monitoring programs

What we offer

Vast opportunities to learn and move up and across our global organisation
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan — including health, finance, and wealth benefits
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Principal AME Equipment Engineer, Battery

We're looking for an experienced Principal Advanced Manufacturing Engineering Eq...

Location

United States , Garden Grove

Salary:

170000.00 - 190000.00 USD / Year

Harbinger Motors

Expiration Date

Until further notice

Requirements

13+ years of experience in advanced manufacturing engineering
At least 8+ years focused on battery manufacturing equipment in automotive EV or a related high-volume manufacturing industry
Proven experience with factory layout planning, utility integration, and scaling manufacturing lines within new or expanding facilities
Bachelor's or Master's degree in Mechanical Engineering, Electrical Engineering, Mechatronics, Industrial Engineering, or a related technical field
Deep expertise in various cell, module & battery manufacturing processes (e.g., cell testing, assembly, welding, laser cleaning, foaming and module/pack assembly)
Proven history of bringing new, complex manufacturing equipment online from concept to high-volume production
Strong understanding of automation principles, robotics, machine vision, and control systems in manufacturing
Experience with equipment specification, procurement, vendor qualification, and contract negotiation
Proficiency in CAD software (e.g., SolidWorks, 3DX, AutoCAD) for reviewing equipment designs and layouts
Ability to perform root cause analysis and implement effective corrective actions for equipment issues

Job Responsibility

Define and implement the long-term equipment strategy for battery cell and pack manufacturing
Lead the entire equipment lifecycle: concept, specification, vendor selection, design review, installation, commissioning, ramp-up, and continuous improvement
Lead the planning, layout, and installation of new battery manufacturing lines within existing or new facilities
Act as the technical expert for battery manufacturing equipment
Partner with equipment suppliers, leading technical discussions, negotiating specifications, and ensuring on-time delivery and performance
Collaborate with battery design and product engineering teams to optimize designs for manufacturability (DFM) and assembly (DFA) on automated equipment
Drive continuous improvement for equipment performance, uptime, yield, and cycle time through data analysis, root cause analysis, and robust solutions
Ensure all equipment designs and installations meet safety standards, environmental compliance, and relevant industry regulations
Mentor and guide less experienced engineers
Work with R&D, Quality, Operations, Supply Chain, and Facilities teams for successful project execution and integration of new equipment

What we offer

Comprehensive Health, Dental & Vision (HDV) – 100% employee covered
Early-stage Stock Options
Robust Retirement Savings (401k, HSA, FSA)
Generous Paid Time Off (PTO) & Parental Leave
Annual Vacation Bonus
Wellness & Fertility Benefits
Cell Phone Stipend
Complimentary Meals & Stocked Kitchens

Fulltime

Process Engineer II

The Process Engineer II role is focused on floor operations and eliminating wast...

Location

United States , Philadelphia

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor of Science in Engineering or equivalent required
3-7 years relevant engineering experience
Familiarity with general industrial production equipment
Effective communication skills (verbal and written form)
Effective at leading project teams and interfacing with customers and operations personnel
Ability to prepare a project plan
Must possess and demonstrate motivational and leadership qualities
Must possess excellent problem solving and analytical skills
Must be well organized along with being detail and multi-task oriented
Fully competent in the use of computer software – Microsoft Windows, Microsoft Word, Microsoft Excel and Microsoft Power Point

Job Responsibility

Identify and mitigate packaging issues for existing business through strong engineering and process improvement methods
Provide technical leadership for new product launches
Lead continuous improvement activities
Specify, purchase, and commission new equipment and manage capital finances
Provide technical support for new business (Sales/Business Development Support)
Analyzes sales requests to determine equipment, tooling, or delivery systems needed
Performs Engineering review of all components for new jobs (size, capability of equipment, bar codes)
Applies sound engineering principles to design new equipment, production lines and component layout
Conducts and/or participates in customer meetings and attends occasional off-site meetings
Interacts with Sales and customers to determine requirements for new products/orders

Fulltime

Continuous Improvement Lead – Commissioning & Qualification

Amgen

Location:
India , Hyderabad

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 16, 2026

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