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Job Details

Validation Engineer - Bahamas - 12 months

Company: Hobson Prior
Location: Bahamas
Reference: PBCATH
Closing Date: 20 Aug 18
Type: Contract
Salary (£): On Application
Benefits: Excellent package

Job Summary:

The Validation Engineer is responsible for the execution and maintenance of the Site Validation Master Plan for our client and ensures it is aligned with the current regulations and the Qualification and Validation cGMP's.

Requirements:

The Position

  • The Validation Engineer is responsible for the execution and maintenance of the Site Validation Master Plan for our client and ensures it is aligned with the current regulations and the Qualification and Validation cGMP's.
  • She/he is also responsible for providing hands on support, guidance, and direction to all the involved areas in the organization, with respect to validation activities.
  • The Validation Engineer will be based at corporate headquarters in Freeport, Grand Bahama in the Bahamas, but may be required to travel from time-to-time to the customer's locations in the USA and Canada.

Responsibilities 

  • Equipment, utilities, and facilities Qualification and Validation: reviews and lead the execution of all qualification and validation protocols and reports.

Cleaning Validation

  • Executes all activities to maintain the Validation Master Plan and related Standard Operating Procedures (SOP's)
  • Executes the working plans for the Validation and revalidation of the Cleaning Methods
  • Coordinates the sampling with production and QC labs teams in order to ensure that the samples required are taken expeditiously.
  • During Process Validations ensure that the protocols and reports are completed by providing all the necessary guidance and direction to the protocols and reports and to the teams executing them

Analytical Instrumentation Qualification and Validation

  • Executes and maintain the Qualification Master Plan
  • Provides Review and Advice with regards to the current Analytical Instrumentation Qualifications and Validation and has oversight during the execution of such validations.
  • Review / execute/ and has oversight of the System Validations related to Analytical Testing equipment
  • Participates in all risk assessments / analysis that have impact in the Qualification and Validation processes

Change Controls and Deviations

  • Review and evaluates all changes that has resulted from validations and those can have an impact on validation or validated equipment
  • Review and evaluates all deviations detected during the execution of qualifications and deviations and will participate and support all areas in the deviations that can have an impact on validated processes.

Documentation

  • Responsible for the review and approval of all documentation that regulates or impact the state of validation of any process, and qualification of any equipment, facility, and utility involved in the manufacturing of our products.
  • Provides all the necessary data, facts, and information required in any process review or Management Meeting.

Validation Key Performance Indicators (KPl's)

  • Collects and periodically reports all data necessary to inform the state of validation for the site with special interest in the trends so data can drive the decision making for the site.

 

Qualifications and Experience

  • The successful candidate will likely have expertise and a strong leadership and technical background in API manufacturing.
  • At least 10 years of hands on experience in Equipment Qualification and Process Validations in the Pharmaceutical Industry under cGMP regulations with API experience as well, or experience with a B.S., M.S. or MBA in Science, Biology, Chemistry, or Engineering.
  • The successful candidate will have a good track record of building high-performing, multi­ function pharmaceutical leadership teams.
  • The Validation Engineer will provide examples of improved performance by his/her teams across an array of metrics related to financial performance, quality, regulatory compliance and customer service.
  • The Validation Engineer should have at least 10 years of hands on experience in a supervisory and / or managerial position within the Pharmaceutical Industry.
  • The successful candidate will evidence good awareness and demonstrated experience of the fundamentals of the pharmaceutical supply chain, technical operations, quality and regulatory.
  • The successful candidate will demonstrate strong strategic and tactical awareness.
  • The successful candidate will evidence a generic or CMO pharmaceutical industry perspective and experience base.
  • The successful candidate will evidence executive communication skills, both oral and written.
  • The successful candidate will have a proven track record in leading and developing organizations to consistently deliver results, both in terms of ongoing operations and with respect to quick resolutions of issues as they arise.
  • The successful candidate will demonstrate strong ethical principles and good business judgment; is skilled in making risked based decisions from a regulatory, ethical and business perspective.

 

If this role is of interest please contact me directly on frankie.cunningham@hobsonprior.com or 01892 612 612 

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Contact Information:

Address:  Hobson Prior International Ltd
Wellington Gate
7-9 Church Rd.
Tunbridge Wells
kent
TN1 1HT
England
Tel:  01892 612 612
Fax:  01892 612 613
Website:  Visit Our Web Site

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