Validation Jobs

The primary functions of the Validation Specialist are to provide appropriate validation documentation for validation activities at the Fort Dodge facility, track and facilitate the completion of those activities, perform and/or assist with protocol execution, and provide adequate training within the Technical Services department.

RESPONSIBILITIES:

• Develop assigned protocols, reports and Validation Master Plans for the Parenteral production facility.
• Supervise assigned validation activities for the Parenteral production facility and interact as part of the focus factory team supporting that area..
• Review validation documentation for cGMP compliance.
• Interface with regulatory inspectors (supervised).
• Assist with the completion of assignments to meet major department objectives.
• Perform duties as assigned by the Manager(s) or Associate Director of Technical Services

Independently reviews and approves validation documentation including specifications, protocols and reports with a focus on cGMP impact and validation lifecycle requirements. Independently leads the QA input to validation projects in support of commercial manufacturing. Provides direction to project teams on compliance/technical issues related to validation efforts to achieve compliance with company policies and government regulations. Mentors junior level staff, providing coaching and guidance on company policies and regulatory requirements.

Job Responsibilities

*Independently reviews validation, calibration and corrective maintenance documentation for compliance with company policies and government regulations.

*Document approval including specifications, protocols and reports with a focus on cGMP impact and validation lifecycle requirements.

Wyeth seeks a Validation Specialist in Andover, MA to coordinate & execute validation engineering activities consisting of development & implementation of biopharmaceutical manufacturing processes & equipment validation.

Master's in Industrial Engineering or related field and over 18 months of experience in bio-manufacturing process and equipment validation in compliance with FDA regulatory requirements within the pharmaceutical industry. In lieu of the required Master's degree, employer will accept a Bachelor's degree in engineering, or a biological or chemical science plus an additional 4 years of biopharmaceutical manufacturing process and equipment validation experience.

Relocation is not available for this position.

Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs.

The primary functions of the Validation Specialist are to provide appropriate validation documentation for validation activities at the Fort Dodge facility, track and facilitate the completion of those activities, perform and/or assist with protocol execution, and provide adequate training within the Technical Services department.

RESPONSIBILITIES:

• Develop assigned protocols, reports and Validation Master Plans for the Parenteral production facility.
• Supervise assigned validation activities for the Parenteral production facility and interact as part of the focus factory team supporting that area..
• Review validation documentation for cGMP compliance.
• Interface with regulatory inspectors (supervised).
• Assist with the completion of assignments to meet major department objectives.
• Perform duties as assigned by the Manager(s) or Associate Director of Technical Services.

Wyeth in Andover, MA seeks an Associate Director/Director to direct the QA Validation support for all validation activities at the Andover Manufacturing Facility relating to the validation of manufacturing systems, utilities, laboratory equipment, process automation and enterprise computer systems. Requirements: BS or equiv. in Biology, Chemistry, Engineering or related. Exp. must include at least 10 yrs in progressively responsible positions in Quality Assurance and/or validation of pharmaceutical/biopharmaceutical manufacturing processes in a cGMP environment, 5 yrs of which must include validation of computer systems in accordance with cGMP regulations.

Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs.

For more information and to apply online, please visit us at: www.wyeth.com/careers

Accomplish validation tasks on small to medium projects independently, provides validation of cGMP Laboratory Instruments. Based on manufacturers and laboratory specifications, performs validation projects that includes authoring protocols, executing validation protocols and writing reports of validation results. Represent the Validation department to contribute to Validation Master Planning on specific projects. Ensures timely resolution of all deviations and changes that occur during the execution phase. Develop validation standards, procedures, and guidelines for the utilization within the Validation department with guidance from supervisor. Leads the validation activities for medium scale projects. Will represent the Validation department on cross-functional site teams

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Join us and experience our culture first-hand — one of strong ethics & integrity, diversified experiences and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The Quality & Validation Specialist is responsible for documenting objective evidence that the software, hardware, equipment, operating procedures, total solution and operational environment consistently produces all pre-determined requirements. The Quality & Validation Specialist also provides training and guidance to the team concerning the authoring of validation deliverables, good documentation and testing practices.
Assist in the development, maintenance, and communication of the validation master plan.
Develop, review and/or maintain Quality/Validation/Compliance & IT SOPs, Protocols, Test Plans, and Test Protocols as required.

Join us and experience our culture first-hand — one of strong ethics & integrity, diversified experiences and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The basic function of the Operation Scientist position is to execute pre-defined scientific studies and associated tasks by following specified techniques and methods. Work is supervised by scientific staff who typically design the studies to be performed. Examples of studies to be performed include:
equipment cleaning validation studies
equipment sterilization studies
lab-scale process performance studies.

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An opportunity exists for an experienced validation professional to join a utility validation group supporting manufacturing facilities at the Andover Wyeth BioPharma site. Responsibilities will include equipment and process reviews, development of qualification test plans and protocols, validation execution activities, review and analysis of validation test results, and revalidation assessment for validated systems. Areas of focus are purified water systems, clean steam systems, CIP systems, HVAC and compressed gas systems.
Successful candidate must be able to work in a team environment and foster professional relationships with departments such as site Quality and Engineering.

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With proven ability to accomplish projects independently, provides validation engineering of cGMP equipment systems and processes. Based on engineering specifications, performs validation projects that includes authoring protocols, executing validation protocols and writing reports of validation results. Leads the validation activities for large capital projects. Ensures timely resolution of all deviations and changes that occur during the execution phase. Assists in developing validation standards, procedures, and guidelines for the utilization within the Validation department. Will represent the Validation department on cross-functional site teams. Provides guidance to more junior members of the Validation Engineering staff.

Job Responsibilities