The IT Validation Specialist is responsible for supporting computerized systems, software, and IT infrastructure that have been newly installed, upgraded, replaced, and/or modified in a GxP facility as well as its related support areas, including but not limited to facilities/engineering and Quality Assurance. He or she is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success and meets business needs.
Essential Responsibilities
• Follows standard operating procedures including those for change control, application configuration, issues escalation, and incident handling
• Provides support for scientific and corporate systems and specialized applications including environmental monitoring, validated laboratory systems, and facility security systems
• Creates and administers user accounts for specialized scientific applications
• Maintains version control of all validated software that is installed on end user workstations
• Participates in the qualification and/or validation of all managed company IT computing environments, systems, and software
• Participates in the qualification and/or validation of all BioAgilytix Europe laboratory equipment and software
• Maintains the qualification and/or validation status of the IT infrastructure and systems by following policies and standard operating procedures
• Tracks and resolves exceptions and deviations during qualification activities
• Assists with validation contractors to complete on-site validation, as needed or required
• Performs duties with minimal oversite
Additional Responsibilities
• Other duties as needed
Minimum Preferred Qualifications
Education/Experience:
• Bachelor’s degree in engineering, information technology, computer science, or related discipline or equivalent demonstrated work experience
• Not less than five (5) years’ experience providing IT operational support and configuring application servers
• Not less than three (3) years’ experience in pharmaceutical/GxP/regulated environment
• Direct hands-on experience with computer systems validation and/or equipment qualifications strongly preferred
• Experience executing test plans and documenting results, preferred
Skills:
• Knowledge of GxP regulatory requirements for computerized systems validation and good documentation practices
• Ability to apply SOPs, work instructions, and regulatory requirements to the validation of computerized systems
• Demonstrated knowledge of IT infrastructure and information database systems
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company procedures/policies
• Ability to work in fast-paced environment where multiple projects are in process and must be completed in a timely manner
• Ability to document system configurations (including creating system diagrams)
• Advanced computer skills in Microsoft Office (Word, Excel, Outlook, etc.)
• Excellent written and verbal communication skills; ability to communicate effectively with a wide variety of people in a professional manner, face to face, on the telephone and in writing
• Versatility, flexibility, and willingness to work within constantly changing priorities
• Ability to deal effectively with a diversity of individuals at all organizational levels
Supervisory Responsibility
• This position has no supervisory responsibilities
Supervision Received
• Infrequent supervision and instructions
• Occasionally exercises discretionary authority
Working Environment
• Primarily office
• Occasional laboratory/clinical environment
• Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
Physical Demands
• Ability to work in an upright and/or stationary position for up to eight (8) hours per day
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office equipment
• Frequent mobility needed
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
• Light to moderate lifting and carrying (or otherwise moving) objects, including files, equipment, and laptop computer, with a maximum lift of 20 pounds
• Ability to access and use a variety of computer software
• Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
• Frequently interacts with others to obtain or relate information to diverse groups
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; requires multiple periods of intense concentration
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
• Ability to perform under stress and multi-task
• Regular and consistent attendance
Position Type and Expected Hours of Work
• This is a full-time position
• Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
• Occasional weekend, holiday, and evening work required, Occasional travel required
BENEFITS AND OTHER PERKS
Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (10 scheduled; 3 floating), 401k with Employer Match, Employee Referral Program
COMMITMENT TO EQUAL OPPORTUNITY
BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.
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