Manager, C&Q Document Preparation (Manufacturing Support) Job at Amgen (Hyderabad)

Manager, C&Q Document Preparation (Drug Product)

In this vital role, you will lead the preparation and delivery of commissioning ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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

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

Fulltime

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

In this vital role, you will lead the preparation and delivery of commissioning ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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

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

Fulltime

Manager, C&Q Document Preparation (Drug Substance)

In this vital role, you will lead the preparation and delivery of commissioning ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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

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

Fulltime

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

In this vital role, you will lead the preparation and delivery of commissioning ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

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

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

Fulltime

Systems Engineer

Arcfield was purpose-built to protect the nation and its allies through innovati...

Location

United States , Fort Meade

Salary:

125914.83 - 218941.46 USD / Year

Arcfield

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering plus 10-12 years of relevant experience, or a Master's degree plus 8-10 years of relevant experience, or a PhD plus 5-7 years of relevant experience
Relevant experience must be in engineering systems over their lifecycle (for example, conception, design & development, testing, production, distribution/deployment, operation, maintenance & support, decommissioning)
Degree must be in Engineering or a relevant technical field (for example, computer science, mathematics, or physics)
Active TS/SCI with Poly required
For all of the above degrees, if program is not ABET accredited, it must include specified coursework
Specified coursework includes courses in differential and integral calculus and 5 of the following 18 areas: (a) statics or dynamics, (b) strength of materials/stress-strain relationships, (c) fluid mechanics, hydraulics, (d) thermodynamics, (e) electromagnetic fields, (f) nature and properties of materials/relating particle and aggregate structure to properties, (g) solid state electronics, (h) microprocessor applications, (i) computer systems, (j) signal processing, (k) digital design, (l) systems and control theory, (m) circuits or generalized circuits, (n) communication systems, (o) power systems, (p) computer networks, (q) software development, (r) any other comparable area of fundamental engineering science or physics, such as optics, heat transfer, or soil mechanics

Job Responsibility

Assist in the development of system requirements, specifications, and design plans based upon engagement with stakeholders to effectively understand gaps and challenges in tools, systems, and tradecraft
Analyze stakeholder requirements and conduct feasibility studies
Assist in the development of system metrics (measures of effectiveness and technical performance measures) based upon specified design considerations
Assist in the development and documentation of operational and support concepts
Perform functional analysis including decomposition of requirements to low-level functions, allocation of performance and other limiting requirements to all functional levels, define and refine internal and external functional interfaces, and integrate a functional architecture
Perform function synthesis to include the transformation of functional architectures to physical/solution designs, defining alternative concepts, configuration items and elements, defining system/software interfaces, and identifying preferred systems through value modeling
Provide engineering support to planning, integration, and testing support during the testing and evaluation of prototypes and systems to verify availability, quality, and documentation conformance
Prepare test plans, procedures, and reports
test and analyze results
Integrate engineering specialties into the systems development process, when required

What we offer

Health Insurance
Life Insurance
Paid Time Off
Holiday Pay
Short Term and Long-Term Disability
Retirement and Savings
Learning and Development opportunities
wellness programs

Fulltime

Continuous Improvement Lead – Commissioning & Qualification

Amgen is seeking a Continuous Improvement Lead – Commissioning & Qualification (...

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 implementing or supporting digital transformation initiatives within Engineering, Validation, or Technical Operations environments
Knowledge of ASTM E2500, ISPE guidance, or modern risk-based commissioning and qualification approaches
Experience driving cross-site or global process standardization initiatives
Experience in GMP commissioning, qualification, validation, or technical operations in a regulated pharmaceutical or biotechnology environment
Experience implementing or supporting Kneat or other electronic validation / digital documentation platforms
Experience leading continuous improvement, digital enablement, or process standardization initiatives across engineering or technical operations programs
Experience developing metrics, dashboards, or reporting tools using PowerBI, Tableau, Smartsheet, or similar analytics platforms
Strong understanding of risk-based qualification methodologies and lifecycle validation approaches

Job Responsibility

Lead continuous improvement initiatives focused on C&Q document preparation, digital C&Q execution, and process standardization
Establish and maintain governance for C&Q digital tools, documentation standards, and continuous improvement initiatives across Engineering projects and sites
Drive optimization, governance, and adoption of Kneat and other digital validation tools across Engineering projects and manufacturing sites
Develop and maintain standardized templates, workflows, and best practices supporting digital commissioning and qualification execution
Partner with Engineering, Validation, Quality, Manufacturing, Facilities, and Digital Technology teams to identify and implement process and technology improvements
Establish and monitor performance metrics and reporting to measure efficiency, documentation quality, and program effectiveness
Analyze operational data and program metrics to identify opportunities to improve efficiency, compliance, and execution consistency
Lead implementation and adoption of standardized C&Q practices, templates, and procedures across Engineering projects and sites
Provide training, coaching, and user support for Kneat and other digital tools used in C&Q execution
Ensure digital processes and documentation practices align with GMP requirements, data integrity standards, and regulatory expectations

New

IT Training Lead

The IT Training Lead will drive technology learning and user adoption across the...

Location

United States , Delray Beach

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Experience in IT training, instructional design, technical enablement, or learning and development
Strong knowledge of Microsoft 365
Excellent communication, facilitation, and content development skills
Ability to translate technical concepts into practical, user-friendly training.

Job Responsibility

Design, develop, and deliver IT training programs in instructor-led, virtual, and self-paced formats
Take lead in the Microsoft Copilot and AI training strategy, including onboarding, advanced use cases, responsible AI usage, and ongoing enablement
Partner with IT leadership to support new technology rollouts, system upgrades, and digital transformation initiatives
Create and maintain training content, including videos, guides, tutorials, and job aids
Identify skill gaps and develop targeted learning solutions to improve adoption and productivity
Gather feedback and measure training effectiveness to continuously improve programs.

New

K Kitchen Representative

The position includes, but is not limited to, the following essential job duties...

Location

United States , New Albany

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Excellent communication skills
Team player who can work well with others or independently
Acts with integrity
keeps commitments
Contagious positive attitude
Focuses on achieving results while having fun
Frequently bend, twist at waist, kneel, squat, stand, and walk
Occasionally climb and descend ladders
Tolerate extreme cold and hot temperatures and work in and around fryers, ovens, grills, coolers, freezers, sharp objects, and loud noises
Reach, grasp, and manipulate objects with hands for entire shift, including reaching for objects overhead

Job Responsibility

Provides excellent guest service in a fast and friendly manner
Maintains a clean restaurant environment by cleaning and performing general housekeeping duties
Prepares and serves food items in accordance with all Brand, Company, and health department regulations
Ensures product quality, food safety, and operational standards are met
Keeps accurate cash, sales, and inventory control records
Follows all government laws and safety codes
Completes reports on all incidents following our 5-minute rule policy
Lives our Company values: One Team, Do the Right Thing, Takes Ownership, Play to Win

What we offer

Medical, Dental, Vision, Term Life and AD&D plans
Flexible spending and health savings accounts (FT)
Vacation paid time off
Company holidays paid at time and a half
Matching 401(k)
Tuition Reimbursement
Stock Purchase Plan
Employee Discount Program
Discount Meal Benefit
Wellness Plan

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Manager, C&Q Document Preparation (Manufacturing Support)

Job Description

Job Responsibility

Requirements

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