Lyophilization Technology, Inc. (LTI), established
in 1992, is a unique Contract Development and Manufacturing
Organization enjoying a leadership position in the health care and
related industries. 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 Engineering
Specialist. The Validation Engineering 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 other staff and clients.
Responsible for creating, reviewing, revising and approving
documents with cGMP impact that include standard operating
procedures, work instructions, test methods, equipment
qualification and validation packages.
Represent the Validation function in the review and approval
of Change Controls involving equipment and processes.
Develop validation requirements for projects related to new
equipment, processes, and facilities. Responsible for developing
and documenting Master Validation Plans and for communicating
validation approach and requirements with customers.
Preparation, coordination and execution of validation
protocols and reports in support of project schedule. Support
communication of validation approach and requirements with
customers. Responsible for supervising the execution and
summarization of validation activities, including but not limited
to operations, cleaning, HVAC (CAS system), Purified Water
systems, computer systems, and serialization systems.
Coordinate contracted and shared validation engineering
resources in support of implementing development projects as required.
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.
Investigate or oversee investigations for non-conformances
related to execution of validation protocols. Support the
investigation of customer complaints specific to related areas.
Direct teams supporting validation executions including
technicians, mechanics, Quality personnel, vendor technicians, and
Design qualification or validation studies to ensure equipment
and processes are suitable for the intended use.
Ensure site validation schedule is maintained.
Analyze data from validation and qualification studies.
Act as internal SME regarding validation topics.
Provide training in process validation and equipment
qualification for staff.
Evaluate alternate or new technology to assist in validation studies.