IT Operations Support Specialist

Kelly Services; Manatí (PR); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Retirement plan

Holiday pay

Job summary

Kelly Services is seeking a dedicated IT professional to provide operational support for computerized systems across Manufacturing, QA, Facilities, and Utilities in a pharma setting in Puerto Rico. You will lead validation activities and ensure compliance with 21 CFR Part 11 and related regulatory standards.

The role requires a Bachelor's or Associate degree and 2+ years in pharma IT, with strong English/Spanish communication and a readiness to work extra hours as needed.

Qualifications

• Bachelor's Degree in Computer Science, IT, Engineering, Secretarial Sciences, Business Administration, or related field; or Associate Degree with equivalent experience.
• Minimum two (2) years in pharmaceutical manufacturing, quality operations, computerized systems administration, or software development.
• In-depth knowledge of design, installation, commissioning and validation/qualification of computerized systems in pharma production.
• Proficient knowledge of software development life cycle concepts, change control systems, and FDA/EMEA regulatory requirements including 21 CFR Part 11.
• Knowledge of client server environments, Windows, and relational databases (Oracle, SQL, etc.).
• Knowledge of SAP/R3 highly desirable.
• Excellent communication in Spanish and English.
• Willing to work extra hours when necessary.

Responsibilities

• Provide operational IT support on computerized systems in Manufacturing, QA/Labs, Facilities and Utilities.
• Lead the validation team in design, development and execution of validation plans and protocols for scope systems.

Skills

Communication skills

FDA 21 CFR Part 11

Life cycle & Change control

Infinity knowledge

Education

Bachelor's or Associate degree in related field

Tools

SAP/R3

Oracle

SQL

Windows

Job description

At Kelly ® Science, Engineering, Technology & Telecom (SETT), we’re passionate about helping you find a job that works for you. How about this one?

(Estimated length: 5 months)

This job might be an outstanding fit if you have:

• Bachelor's Degree in Computer Science, Information Technology, Engineering, Secretarial Sciences, Business Administration, or a related field; or Associate Degree with equivalent experience.

• Minimum two (2) years of experience in pharmaceutical manufacturing, quality operations, computerized systems administration, or software development.

• INFINITY knowledge.

• In-depth knowledge of the science and computerized systems involved in the design, installation, commissioning and validation/qualification of computerized systems as applied to pharmaceutical production environment.

• Proficient knowledge of computer system development life cycle concepts, change control systems and FDA and EMEA regulatory requirements, including 21 CFR Part 11.

• Knowledge of Computerized Equipment/Operating Systems: Client Server environment, Windows, Relational Databases: Oracle, SQL, etc.

• Knowledge of SAP/R3 highly desirable.

• Excellent communication skills (oral, written and reading) in Spanish and English

• Willing to work extra hours, when necessary.

Job Summary:

Accountable for providing operational IT support on computerized systems in the Manufacturing, Laboratories/QA, Facilities and Utilities areas including the monitoring and management execution of operational site mission critical systems (like: Syncade, Laboratories Information Management System, Network, Communication Devices and stand alone computers). Also accountable for leading the validation team in the design, development and execution of validation plans and protocols for the systems in scope.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type.

• Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.
• As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.
• In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.

Kelly Services is proud to be an Equal Employment Opportunity and Affinitive Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.