Sr Quality Engineer, Validation Job at Baxter (Ahmedabad)

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

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 Engineer, Quality

The Senior Quality Engineer provides engineering support to the plant through pr...

Location

United States , Hayward

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Strong technical writing, investigation and communication skills required
Experience leading cross-functional teams preferred
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo etc.) Familiarity with MINITAB preferred
Minimum 3 years of experience in regulated manufacturing environment
BS degree required, preferably in Engineering, Engineering Technology/ Microbiology/Chemistry degree may be acceptable depending on experience
Applicants must be authorized to work for any employer in the U.S.

Job Responsibility

Leads or assists in developing and implementing new machines/processes/computer systems and in improvements to existing methods
Supports the manufacturing plant through implementation of process improvements
Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, MIP measurements and implements/drives improvements
Manage small projects (both new and improvement) to include cost, change management, implementation, and validation
Leads cross-functional teams
Leads ongoing validation and verification programs such as Continuous Process Verification (CPV), Validation Master Plans, Periodic Reviews, Computer Systems Validation, Stability program and Calibration
Perform statistical analysis to support Quality and Production
Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods
Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal
Composes protocols, final reports, studies, experiments and general information reports for use by management

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Sr Engineer, Quality

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

United States , Hayward

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Strong technical writing, investigation and communication skills required
Experience leading cross-functional teams preferred
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo etc.) Familiarity with MINITAB preferred
Minimum 3 years of experience in regulated manufacturing environment
BS degree required, preferably in Engineering, Engineering Technology/ Microbiology/Chemistry degree may be acceptable depending on experience
Applicants must be authorized to work for any employer in the U.S.

Job Responsibility

Leads or assists in developing and implementing new machines/processes/computer systems and in improvements to existing methods
Supports the manufacturing plant through implementation of process improvements
Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, MIP measurements and implements/drives improvements
Manage small projects (both new and improvement) to include cost, change management, implementation, and validation
Leads ongoing validation and verification programs such as Continuous Process Verification (CPV), Validation Master Plans, Periodic Reviews, Computer Systems Validation, Stability program and Calibration
Perform statistical analysis to support Quality and Production
Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods
Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal
Composes protocols, final reports, studies, experiments and general information reports for use by management
Routes documents in the Document Management System

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
educational assistance programs

Fulltime

Sr Engineer, Quality

The Senior Quality Engineer provides engineering support to the plant through pr...

Location

United States , Hayward

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Strong technical writing, investigation and communication skills required
Experience leading cross-functional teams preferred
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo etc.). Familiarity with MINITAB preferred
Minimum 3 years of experience in regulated manufacturing environment
BS degree required, preferably in Engineering, Engineering Technology/ Microbiology/Chemistry degree may be acceptable depending on experience

Job Responsibility

Leads or assists in developing and implementing new machines/processes/computer systems and in improvements to existing methods
Supports the manufacturing plant through implementation of process improvements
Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, MIP measurements and implements/drives improvements
Manage small projects (both new and improvement) to include cost, change management, implementation, and validation
Leads ongoing validation and verification programs such as Continuous Process Verification (CPV), Validation Master Plans, Periodic Reviews, Computer Systems Validation, Stability program and Calibration
Perform statistical analysis to support Quality and Production
Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods
Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal
Composes protocols, final reports, studies, experiments and general information reports for use by management
Routes documents in the Document Management System

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Sr. Quality Engineer

In this critical role, you’ll provide quality oversight and technical leadership...

Location

United States , Buford

Salary:

130000.00 - 149000.00 USD / Year

Beacon Hill

Expiration Date

Until further notice

Requirements

Bachelor’s degree in chemistry, Chemical Engineering, Biomedical Engineering, Radiochemistry, Pharmaceutical Sciences, Biological Sciences, or related field
A Minimum of 5 years of experience in quality engineering, quality assurance, or validation within regulated environments
Experience working with radioisotope production, radiochemistry, pharmaceutical manufacturing, or nuclear materials is REQUIRED
Experience supporting Drug Master File (DMF) submissions or pharmaceutical regulatory filings preferred
Experience supporting process validation, equipment qualification, and GMP documentation
Strong knowledge of cGMP and regulated quality systems (FDA, ISO, pharmaceutical, or medical device)
Working knowledge of radiochemistry, radioisotope production, or nuclear materials handling preferred
Experience with risk management methodologies, deviation investigations, and CAPA systems
Strong technical writing and documentation skills supporting regulated manufacturing environments
Ability to translate development activities into compliant production documentation and regulatory support packages

Job Responsibility

Ensure compliance with 21 CFR Parts 210 and 211 and/or 21 CFR Part 212 where applicable to radioisotope production activities
Support implementation and maintenance of quality systems consistent with pharmaceutical cGMP requirements
Provide quality oversight for radioisotope production, purification, packaging, and distribution processes
Participate in internal audits and regulatory inspections
Develop, review, and approve SOPs, batch production records, validation protocols, qualification documentation, and technical reports
Ensure production and development documentation complies with data integrity and recordkeeping requirements
Support development and maintenance of master batch records and production documentation
Lead or support validation and qualification activities for radioisotope production processes
Develop and execute validation protocols
Support qualification of production equipment, hot-cell systems, and laboratory instrumentation

What we offer

Career growth opportunities
Work on innovative projects with real patient impact
Collaborative, mission-driven culture
Competitive benefits package

Fulltime

Sr Quality Engineer

Being an Engineer at Baxter means you play a critical role in helping us achieve...

Location

United States , Irvine

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BA or BS in Engineering with 3 to 5 years related experience or demonstrated performance within Quality Engineering
Master’s degree can be used in lieu of 2 years of related experience
Lean or Six Sigma Green Belt or higher preferred
demonstrated experience on process validation and risk management for medical device
engineering depth and ability to understand product and process operating principles
strong verbal and written communication skills
documentation practices (cGDPs)
self-motivated
strong interpersonal skills
ability to update procedures and modify processes to simplify complexity and improve efficiencies

Job Responsibility

Provide Quality Engineering support to one or more product lines at the Irvine facility
support manufacturing operation from raw materials to finished device
maintain Risk Management process and related documentation
closely interact with product design and vigilance functions to address quality issues and facilitate continuous improvement of product quality
support sustaining of production processes in a state of control and compliance through planning, execution and implementation of process validation and controls
author and review validation processes and procedures
make recommendations for changes and/or improvements
evaluate all relevant operational data, reports, statistics and documentation related to manufacturing process and product performance
assure product compliance to specifications through implementation of inspection criteria and procedures
develop and analyze statistical data and product specifications to ensure product quality

What we offer

Support for Parents
Continuing Education/Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Sr Quality Engineer

This position provides Quality Engineering support to one or more product lines ...

Location

United States , Irvine

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Minimum of a BA or BS in Engineering having a minimum of 3 to 5 years related experience or demonstrated performance within Quality Engineering
A Master’s degree can be used in lieu of 2 years of related experience
Engineering or Business Administration major is preferred
Lean or Six Sigma Green Belt or higher is preferred
Demonstrated experienced on process validation and risk management for medical device
Engineering depth and ability to understand product and process operating principles, control points and methods, design and process interactions and end user impact
Must have strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess strong interpersonal skills
Must be able to update procedures and modify processes to simplify complexity and improve efficiencies
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time

Job Responsibility

Evaluate all relevant operational data, reports, statistics and documentation related to manufacturing process and product performance in the field, in order to generate proactive and timely actions when needed to reduce CIPM
Assure product compliance to specifications through implementation of inspection criteria and procedures in operation’s processes
Drives quality and manufacturing improvements to ensure our processes are in state of control
Develop and analyze statistical data and product specifications to ensure product quality
Apply standard operating practices and problem-solving methodology
Perform root cause investigation analysis and prepare reports, for negative trends of process or product failures or critical characteristics not being met
Document such actions within the quality system as appropriate (NCR/CAPA)
Organize, review and perform computer system validation or other software validation related evaluations to support the Master Validation Plan
Support the data integrity initiatives to relevant systems, processes and equipment
Develop and maintain Risk Management Documentation including software risk for all product families or software defects

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

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Sr Quality Engineer, Validation

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