Executive- Engineering QMS Job at JLL (Mumbai)

Sr Quality Engineer, Validation

This is where you make a difference in our patients' safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification.
To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Manager regarding any non-conformity from planning and execution.
To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Manager and approved by Manager.
To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Track wise.
To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date.
To ensure samples withdrawal during process validation & keep Manager updated about any non-conformity.
To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed. To ensure the CFS closure of respective documents.
To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by the Manager.
To attend training of each protocol before execution of any validation and qualification activity.
To collect data & compile summary report for submission to International Regulatory Affairs (IRA) for queries and ANDA.

Job Responsibility

To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification.
To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Manager regarding any non-conformity from planning and execution.
To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Manager and approved by Manager.
To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Track wise.
To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date.
To ensure samples withdrawal during process validation & keep Manager updated about any non-conformity.
To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed. To ensure the CFS closure of respective documents.
To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by the Manager.
To attend training of each protocol before execution of any validation and qualification activity.
To collect data & compile summary report for submission to International Regulatory Affairs (IRA) for queries and ANDA.

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Sr Quality Engineer, Validation

This is where you make a difference in our patients' safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification
To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Manager regarding any non-conformity from planning and execution
To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Manager and approved by Manager
To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Track wise
To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date
To ensure samples withdrawal during process validation & keep Manager updated about any non-conformity
To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed
To ensure the CFS closure of respective documents
To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by the Manager
To attend training of each protocol before execution of any validation and qualification activity

Job Responsibility

To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification
To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Manager regarding any non-conformity from planning and execution
To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Manager and approved by Manager
To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Track wise
To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date
To ensure samples withdrawal during process validation & keep Manager updated about any non-conformity
To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed
To ensure the CFS closure of respective documents
To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by the Manager
To attend training of each protocol before execution of any validation and qualification activity

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Head of Engineering, Maintenance, and Utilities

The Head-Engineering will lead the Engineering function at the Manufacturing and...

Location

India , Khopoli

Salary:

Not provided

Randstad

Expiration Date

June 25, 2026

Requirements

B.E./B.Tech (Mechanical) with at least 15 years of experience in Maintenance & Engineering Projects
Experience in Chemical / Pharma / Process Manufacturing industry
Strong exposure to utilities, CapEx management, and statutory compliance
Proven leadership capability in managing cross-functional engineering teams
Strong communication and stakeholder management skills

Job Responsibility

Ensure high uptime and reliability of manufacturing and R&D equipment
Drive effective implementation of Planned Preventive & Corrective Maintenance systems
Oversee facility upkeep and statutory equipment inspections
Maintain engineering documentation and audit readiness
Monitor spare parts and engineering inventory
Lead QMS compliance within the engineering function
Oversee O&M of utilities (power, steam, HVAC, compressed air, water systems etc.)
Ensure uninterrupted utility supply to production and R&D
Monitor and control engineering, maintenance, and utility budgets
Drive energy efficiency and cost optimization initiatives

Fulltime

Project Engineer II

This position is responsible for the management and execution of multiple and si...

Location

United States , Birmingham

Salary:

Not provided

Evonik Industries

Expiration Date

Until further notice

Requirements

MS/BS in an engineering or scientific field with a minimum of 3-5 years of project management experience with a well demonstrated level of performance and capability in the completion of large CAPEX projects for internal and external customers up to $5M
Demonstrated experience in developing accurate and well defined project scopes, deliverables, cost estimates, and timelines and successfully executing against those items across multiple simultaneous on-going projects
Understanding of different engineering project phases (conceptual, basic and detailed engineering) is required, including the different scopes, requirements, deliverables and timelines associated with each phase
Knowledge of relevant engineering principles and theories as well as the capability to use and apply standard engineering procedures and techniques, especially in the field of pharmaceutical process and equipment design and specifications, as well as pharmaceutical facility buildouts and expansion (cleanrooms, utilities)
Strong knowledge of fields related to pharmaceutical product development process and multiple drug delivery technologies that includes sterile manufacturing, high potent API manufacturing, filling, lyophilization, sterilization (SIP) and cleaning (CIP)
Demonstrated project engineering experience with facility infrastructure type projects with a strong emphasis on civil and mechanical disciplines for designing and executing facility cleanroom/laboratory buildouts, and pharmaceutical grade utility systems (HVAC, WFI, steam, compressed air, nitrogen, boilers, electrical systems)
Demonstrated experience with leading and participating in ESH safety analysis and reviews such as HAZIDs and PHAs and implementing proper safety designs into projects
Strong knowledge of pharmaceutical standards and guidelines for process and equipment requirements based on FDA, ISPE and BPE guidelines for cGMP operations and CSV, CFR 21 compliance for electronic systems
Strong knowledge and understanding of QMS processes and procedures utilized at the BHM Labs site
Experience with process and equipment qualification such as FATs, SATs, commissioning, IOQs is required

Job Responsibility

Plan, coordinate, and execute assigned projects by effectively using Project Management methodologies (such as MS Project) from conceptual design to financial close for projects up to $5M
Acts as the Engineering Lead for assigned projects and assembles a cross-functional team to drive the engineering activities
Develops project scopes that include complex process designs, project plans, and project deliverables
Identifies equipment lists and specifications with suppliers, creates engineering drawings (PFDs, P&IDs, general arrangement), and specifies facility requirements or modifications to meet the project deliverables
Builds well defined cost estimates and timelines for the project scope
Manages project related procurement processes from initial quoting to final invoicing
Collaborates with Evonik Safety to execute risk and hazard analysis associated with projects and implement any mitigating safety requirements
Performs costs analysis and review alternative project designs to implement best business solutions that optimize costs and functionality
Coordinates and executes all required QMS processes and procedures related to engineering projects
Communicates general project status including cost and timeline forecasts to the client and other project stake holders

What we offer

performance-based remuneration
occupational health benefits
hybrid and flexible working environments with #SmartWork
attractive career paths
high-quality development programs

Fulltime

New

Project Engineer

We are seeking a Project Engineer to support the design and execution of industr...

Location

Canada , Oakville

Salary:

80000.00 - 110000.00 USD / Year

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related technical discipline
5+ years of experience in an engineering role
Experience with mechanical equipment specification and evaluation
Ability to read and interpret P&IDs and PFDs, including material balances
Strong mechanical aptitude and attention to detail
Excellent written and verbal communication skills
Ability to work effectively in a fast-paced environment

Job Responsibility

Perform mechanical design activities for water and wastewater treatment systems
Develop technical specifications and RFQ packages for mechanical equipment
Perform technical bid evaluations and equipment selection
Size and specify pumps, blowers, compressors, vessels, tanks, filters, piping systems, valves, and chemical feed systems
Ensure designs comply with engineering standards, customer specifications, contractual requirements, and applicable codes
Review engineering drawings, bills of materials, and technical documentation for accuracy and completeness
Coordinate process and mechanical design reviews
Support issue resolution related to design, construction, and start-up activities
Maintain compliance with Quality Management System (QMS) requirements
Collaborate with project teams and stakeholders throughout project execution

Fulltime

QMS Manager

The Quality Management System Manager ensures that ICEYE’s quality system is emb...

Location

Finland , Espoo

Salary:

Not provided

ICEYE

Expiration Date

Until further notice

Requirements

5+ years in quality, engineering, operations, compliance, or process improvement roles
Degree in Engineering, Quality, Business, or related field
Strong experience with digital QMS systems and data-driven improvement methods
Strong knowledge of QMS standards (ISO 9001 required
AS9100 or similar beneficial)
Experience with quality tools and risk management (RCA, CAPA, FMEA, PDCA, risk assessments)
Audit experience
Lead Auditor certification preferred
Excellent communication, documentation, and stakeholder management skills
Ability to drive cross-functional alignment and continuous improvement

Job Responsibility

Owns the structure, documentation, and effectiveness of ICEYE Quality Management Systems
Ensures compliance with relevant standards (e.g., ISO 9001, AS9100, customer-specific requirements)
Develops and executes the QMS strategy and improvement roadmap
Ensure compliance with regulatory, customer, and industry requirements
serve as the main point of contact for auditors and certification bodies
Design, document, and optimize core business processes
facilitate process mapping and continuous improvement activities
Plan and manage internal audit programs
coordinate external audits and ensure timely corrective action closure
Maintain controlled documentation, change control processes, and system lifecycle management

What we offer

Occupational healthcare, occupational, and accident insurance
A yearly benefit budget to spend as you wish (i.e. on sport, transport, bike benefit, wellness, lunch, etc.)
Phone subscription with iPhone of choice
Relocation support (i.e. flight tickets, accommodation, relocation agency support)
Time for self-development, research, training, conferences, or certification schemes
Inspiring and collaborating offices and silent workspaces enable you to focus

Fulltime

Engineer

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States , Cambridge

Salary:

88281.00 - 119439.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Master's degree
OR Bachelor's degree and 2 years of Engineer experience
OR Associate's degree and 6 years of Engineer experience
OR High school diploma / GED and 8 years of Engineer experience

Job Responsibility

Lead end-to-end preparation and execution of Change Controls, including defining scope, rationale, and supporting documentation
Partner with Change Owners, Document Owners, and SMEs to align timelines, impact assessments, and approvals
Author and/or support redlining and finalization of controlled documents
Ensure completeness, accuracy, and compliance of change records within the Quality Management System
Support presentation of changes at Change Control Boards (CCBs)
Support development and maintenance of the Design History File
Support tasks within one or more of the Design for Robustness disciplines: Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM
Collaborate across robustness disciplines to identify risks and mitigations, opportunities, and best trade-off solutions
Collaborate closely with manufacturing, quality, and suppliers to improve product robustness and reduce variation-driven failures
Apply systems-level thinking to anticipate how design decisions impact downstream manufacturability and performance

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives

Fulltime

Quality Systems Engineer

Millennium Space Systems, a part of Boeing Defense, Space and Security (BDS), is...

Location

United States , El Segundo; Los Angeles

Salary:

74800.00 - 131250.00 USD / Year

Boeing

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Physics, or a related STEM discipline
or 4+ years of equivalent Quality Systems Engineering experience in lieu of a degree
3–5 years of experience in aerospace and/or defense manufacturing in a quality systems role
Expert knowledge of QMS requirements and auditing in a complex product environment, with demonstrated experience in one or more of the following standards: AS9100D, ISO 9001:2015
This position requires the ability to obtain a US Security Clearance for which the US Government requires US Citizenship
A final U.S. clearance Post Start is required

Job Responsibility

Develop, lead, and manage the execution of the QMS and its top-level processes, ensuring alignment with AS9100D, ISO 9001, customer, and regulatory requirements
Build and maintain the internal QMS roadmap for tools, capabilities, and processes to match program growth, new product introductions, and customer requirements
Partner with Engineering, Manufacturing, and Global Supply Chain to develop processes, digital tools to meet QMS requirements and advance new quality capabilities
Become a systems expert for QMS tools, processes, and data sets to enable effective quality execution across all programs
Plan, coordinate, and execute the internal & external audit program against AS9100/ISO standards and customer-specific requirements
manage audit scheduling, resource allocation, and results reporting
Support external certification audits and customer audits
interface with third-party registrars and government auditors as required
Measure, analyze, and report quality system and audit metrics to leadership
identify trends and drive systemic corrective actions

What we offer

competitive base pay and variable compensation opportunities
health insurance
flexible spending accounts
health savings accounts
retirement savings plans
life and disability insurance programs
paid and unpaid time away from work
generous company match to your 401(k)
industry-leading tuition assistance program pays your institution directly
fertility, adoption, and surrogacy benefits

Fulltime

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Executive- Engineering QMS

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