Specialist Manufacturing (Multiple Positions)

Kelly Science, Engineering, Technology & Telecom; Juncos (PR); Hybrid; USD 52,000 - 70,000; Full time

Benefits offered by this job

Paid vacation & holidays

Sick leave

Medical, dental, vision

Retirement savings plan

Transit spending account

Short-term disability

Job summary

Kelly Science & Engineering is seeking a Specialist Manufacturing in Juncos, PR to support manufacturing and quality systems on a multi-greater team. You will manage deviations, CAPAs, investigations, and change controls while ensuring procedures align with current operations.

Ideal candidates have strong experience in biotech/pharma manufacturing, QA, and regulatory knowledge, with fluency in English and Spanish for technical writing and presentations.

Qualifications

• Doctorate or Master’s with 2+ years in manufacturing ops; or Bachelor’s with 4+ years in manufacturing ops.
• Bachelor’s degree in engineering is a plus
• Experience in biotech/pharma manufacturing, QA with increasing responsibility.
• Strong experience managing deviations, non-conformances, investigations, CAPAs, and Change Controls using TrackWise, Veeva, or similar quality systems.
• Experience with Root Cause Analysis, deviation assessments, investigation ownership, and technical report writing.
• Proficiency in Microsoft Office and SAP (ERP) systems.
• Excellent written and verbal communication skills in English and Spanish, including technical writing and presentations.

Responsibilities

• Supporting the execution of manufacturing and quality systems including non-conformances, process validation, procedures, training, and new product introductions.
• Serving as a process owner and document owner for manufacturing procedures, ensuring alignment with current operations.
• Assessing process performance, identifying and implementing process improvements, and providing troubleshooting support on the manufacturing floor.
• Leading or assisting in deviation investigations, authoring investigation reports, and managing non-conformance (NC) and CAPA closures.
• Supporting the establishment and review of process monitoring parameters, collecting and analyzing process data, and preparing quarterly reports.
• Assisting with process validation protocols, data collection, and execution of validation activities.
• Participating in regulatory inspections, new product introduction, process or equipment modification projects, and special initiatives.
• Collaborating with cross-functional teams and supporting change control processes.

Skills

TrackWise

Veeva

CAPA management

Change controls

Root Cause Analysis

Microsoft Office

SAP

Bilingual English/Spanish

Manufacturing operations

Quality assurance

Education

Doctorate

Master’s degree in Engineering/Manufacturing

Bachelor’s degree in Engineering

Tools

TrackWise

Veeva

SAP

Excel

Job description

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

We’re seeking for Specialists Manufacturing (multiple positions) to work at a premier biotechnology manufacturing client in Juncos, PR.

Let us help you grow at work and discover the next step in your career, all while being a vital part of your community.

Shift: Administrative shift (support a 24/7 manufacturing operations, some remote work is possible)

Why You Should Apply To Be Specialist Manufacturing

• Competitive pay with biweekly direct deposit (W-2)
• Hands-on experience supporting critical manufacturing and quality systems in a leading biotechnology environment
• Collaborative, fast-paced, and dynamic workplace with growth opportunities
• Access to extensive training resources and career guidance
• Paid vacation, sick leave, holidays, and eligibility for a Christmas bonus (Must comply with minimum established requirements to qualify.)

This job might be an outstanding fit if you have the following requirements:

• Doctorate OR Master’s degree plus 2 years of Manufacturing Operations experience OR Bachelor’s degree plus 4 years of Manufacturing Operations experience
• Bachelor’s degree in engineering or a related technical discipline is a plus
• Experience in manufacturing, process development, or quality assurance within the biotech or pharmaceutical industry, with progressively increasing responsibility.
• Strong experience managing deviations, non-conformances, investigations, CAPAs, and Change Controls using TrackWise, Veeva, or similar quality systems.
• Experience with Root Cause Analysis, deviation assessments, investigation ownership, and technical report writing.
• Proficiency in Microsoft Office and SAP (ERP) systems.
• Excellent written and verbal communication skills in English and Spanish, including technical writing and presentations.

What’s a typical day as Specialist Manufacturing? You’ll be:

• Supporting the execution of manufacturing and quality systems including non-conformances, process validation, procedures, training, and new product introductions
• Serving as a process owner and document owner for manufacturing procedures, ensuring alignment with current operations
• Assessing process performance, identifying and implementing process improvements, and providing troubleshooting support on the manufacturing floor
• Leading or assisting in deviation investigations, authoring investigation reports, and managing non-conformance (NC) and Corrective and Preventive Action (CAPA) closures
• Supporting the establishment and review of process monitoring parameters, collecting and analyzing process data, and preparing quarterly reports
• Assisting with process validation protocols, data collection, and execution of validation activities
• Participating in regulatory inspections, new product introduction, process or equipment modification projects, and special initiatives
• Collaborating with cross-functional teams and supporting change control processes

Helping you discover what’s next in your career is what we’re all about, so let’s get to work.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. 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.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long‑term opportunity, we’re here to guide you to the next step in your engineering career.

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.