Job Description:
Lyophilization Technology, Inc. (LTI), established
in 1992, is a unique Contract Development and Manufacturing
Organization enjoying a leadership position in the health care
product industry. The company conducts applied research, provides
scientific services and technical support, and manufactures clinical
supplies for freeze dried pharmaceuticals, biologics, diagnostics
and biopharmaceuticals. LTI is located in Ivyland, Bucks County, Pennsylvania.
We have a position opening for a Validation
Specialist. The Validation Specialist is responsible for
coordinating validation activities across all operational areas and
ensuring activities are conducted in a timely manner in accord with
current Good Manufacturing Practice and appropriate regulatory
expectations. Using basic skills and knowledge of appropriate
development laboratory and lyophilized parenteral procedures,
methods and techniques, the Validation Specialist is responsible for
designing and interpreting qualification and validation studies to
meet requirements for intended use. This requires working with and
providing assistance to staff within the Development Sciences and
Clinical Manufacturing groups.
Principal Responsibilities
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Responsible for creating, reviewing, revising and approving
documents with cGMP impact that include equipment qualification
and validation packages.
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Design qualification or validation studies to ensure equipment
and processes are suitable for the intended use.
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Preparation, coordination and execution of equipment
qualification and process validation protocols and reports in
support of project schedule.
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Represent the validation function in the review and approval
of Change Controls involving equipment and processes.
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Develop validation requirements for projects related to new
equipment, processes, and facilities.
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Responsible for developing and documenting Master Validation Plan.
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Direct teams supporting qualification and validation studies
including technicians, mechanics, and quality personnel.
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Ensure site validation schedule is maintained.
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Analyze data from validation and qualification studies.
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Act as internal SME regarding validation topics.
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Provide training in process validation and equipment
qualification for staff.
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Evaluate alternate or new technology to assist in validation studies.
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Participate in customer or regulatory audits as required.
Follow-up on audit observations specific to the site validation
function including assisting in the audit response and monitoring
commitments specific to the related issues.
