Validation Specialist
Posted on :
11-11-2022
Employer Active
1 Vacancy
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Jobs by Experience
5 minimunyears
Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
11-11-2022
Job Description
Req ID : 1667898
Lead new and existing products change implementation review, from process evaluation through
FDA approval and products launch. Execute all related activities to new products introduction and
product changes and Change Control procedures. Assures that the Company complies with all
internal and external standards and regulations.
Provide technical support to Manufacturing, Engineering and Quality areas for the manufacturing
environment of parenteral solutions and medical devices. Manage all New Product introduction and
Product Change Controls related activities with corporate and internal plant resources, to meet
milestones and deadlines. Participate on the evaluation of customer requirements for New Products
and provide suggestions for process/product improvements. Gets involved and/or lead company
teams such as: New Products Team, Change Control Review Board, etc. Lead a functional team for
special projects. Includes perform team meetings, track progress, action items and deliverables.
Report results to management as required by supervisor. Implementation of manufacturing projects
developing timelines and periodic meetings to report projects progress and implementation
strategies in order to meet deadlines. Provides technical information concerning processing
techniques, materials, properties, and process advantages and limitations which affect long range
plant and product engineering planning. Assists and support in the trouble shoot of projects as
required. Able to handle multiple tasks at the same time. Willing to work extra hours, any shift or
Holidays (e.g. shutdowns, extraordinary events). Must be able to keep the work area in the cleanest
and order conditions. Team worked oriented, active participation in Company teams when required.
Review validation protocols and reports for the qualification of manufacturing process, equipment's
and process changes as necessary. Implements changes and follow-up actions to ensure the
effectiveness of the changes. Interface with other Baxter plants and Divisional groups when
required. Support manufacturing/quality functions (Documentation, Laboratories, Process,
Engineering) in the preparation and development of new products process and batch release related
to FOC / Protocols. Able to work with minimum supervision. Should be able to work with multiple
projects and handle multiple tasks at the same time. Teamwork oriented. Communicate effectively at
all Levels.
Requirements
Bachelor s degree in Engineering, Natural Sciences or Bachelors degree with manufacturing
experience minimum of 5 years experience in product development, change control, validations or
related areas; Master degree or PhD with at least 2-3 years of experience will be equivalent.
Ability to discuss normally encountered technical or project management issues, both
verbally and in written form. Ability to work as a collaborative team member with good negotiations
skill. Ability to solve routine design, engineering problems with assistance. Skills in MS Project/MS
Excel and Word applications to do process analysis and technical reports. Knowledge of problem-
solving and statistical techniques. Good interpersonal skills. Traveling is required.
Benefits
Contract Position
Bachelor s degree in Engineering, Natural Sciences or Bachelors degree with manufacturing experience minimum of 5 years experience in product development, change control, validations or related areas; Master degree or PhD with at least 2-3 years of experience will be equivalent. Ability to discuss normally encountered technical or project management issues, both verbally and in written form. Ability to work as a collaborative team member with good negotiations skill. Ability to solve routine design, engineering problems with assistance. Skills in MS Project/MS Excel and Word applications to do process analysis and technical reports. Knowledge of problem- solving and statistical techniques. Good interpersonal skills. Traveling is required.
Employment Type
Full Time
Key Skills
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