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 other staff and clients.
Expected conduct is highlighted in work habits and professional
behavior. Core Competencies identify tasks and activities to be
mastered for the position. Additional responsibilities are skills
and activities in specific assigned functions. Each will be
considered in annual performance reviews.
Developing and documenting Master Validation Plans and for
communicating validation approach and requirements with LTI staff
Develop validation requirements for projects related to new
equipment, processes, and facilities.
Creating, reviewing, revising, and approving documents with
cGMP impact that include standard operating procedures, work
instructions, test methods, equipment qualification and process
Represent the Validation function in the review and approval
of Change Controls involving equipment and processes.
Coordinate scheduling of validation and qualification studies
with area manager to ensure equipment, materials and personnel are
available for performing studies.
Design validation or qualification studies to ensure equipment
and processes are suitable for the intended use.
Preparation and oversee execution of validation protocols and
reports in support of project schedule. Ensure site validation
schedule is maintained.
Coordination, direction and oversight of teams supporting
validation executions including technicians, mechanics, QA
personnel, and vendor technicians.
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.
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.
Work Habits and Professional Behavior
Expected conduct, work habits and professional behavior are
highlighted in this section. Aspects of technical skills and
abilities, along with project management, and an outline of
expectations in fulfilling responsibilities of the position are
described. Each will be considered in annual performance reviews.
Principles and Philosophies
Exemplify principles of LTI’s mission statement.
Exhibit behavior consistent with LTI’s policies, practices and
Contribute to company goals, suggest alternatives and
constantly pursue improvements.
Demonstrate commitment, dedication, cooperation, and positive
behavior; volunteer to complete special projects.
Collaborate with associates, work with others effectively;
willing to vary individual work schedule and assignment as needed
for overall good of the group.
Maintain harmonious working relationships with supervisors,
co-workers, vendors, and clientele by interacting professionally
and appropriately; help to create a hospitable and inclusive work environment.
Continual improvement in practical and technical skills,
suggest and implement improvements, devise new procedures and methods.
Personal and Professional Abilities
Utilize care and safety in completing tasks, considering
safety of self and others while working.
Exercise prudent judgment, consider options and alternative
outcomes, assess potential resolutions, and routinely make
practical, effective decisions.
Follow directions and guidance, acknowledge own errors and
take corrective action.
Punctual, act promptly, effectively use time, set and balance
priorities, expend efforts to complete tasks and meet deadlines.
Self-directed in daily activities, organized and adequate
follow-through for successfully completing activities with limited supervision.
Complete activities and responsibilities in the position
description and other assignments thoroughly and accurately.
Perform as efficiently as possible without jeopardizing
quality; strive to increase productivity while maintaining a high
level of quality.
Adjust to changing situations, learn new and different tasks,
respond appropriately to suggestions for work improvement.
Exhibit ability, knowledge, and skill necessary to perform
effectively; understand the expectations of the job and stay
current with new technologies, methods, and processes.
Creative and offer innovative ideas that contribute to meeting
objectives and goals.
Interpersonal and Communication Skills
Behave in a professional manner and maintain composure in
Good verbal and written communication skills, clear, concise
and conveys understanding.
Provide appropriate quantity and quality of information in a
timely manner to others.
Listen well and understand others' needs.
Ensure dialogue with fellow employees and others is
professional and appropriate.
Accessible and approachable on difficult subjects.
Deal with pressure and conflict in a positive manner.
Technical Skills and Abilities
Follow Standard Operating and Quality Assurance Procedures.
Give appropriate attention to details, observations, and
Accurate, detailed and thorough in recording data and
Ensure processes and plans are scientifically sound, effective
and efficient to achieve a high level of quality.
Know, follow and practice principles of current Good
Manufacturing Practices, always pursue Best Practices.
Possess a working knowledge of procedures and methods to
successfully complete projects.
Demonstrate ability to safely complete containment projects.
Effectively execute activities in clean room environment using
good aseptic processing techniques.