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Biopharmaceutical Manufacturing Associate Jobs in Puerto Rico

CIS International LLC

PR

Approve process validation protocols and reports for manufacturing processes. * Request Quality on ... Associates + 8 years of directly related experience. * High school/GED + 10 years of directly ...

New

BioPharma Consulting JAD Group

Specialist QA

Juncos, PR · On-site

The role provides oversight across manufacturing, environmental monitoring, critical utilities ... Associate's + 8 years directly related experience OR * High School/GED + 10 years directly related ...

Kelly Services

PR

... our top global biopharmaceutical clients in the Barceloneta PR area. With us, it's all about ... The Quality Associate supports the Global Biologics Quality Function within Operations.

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Biopharmaceutical Manufacturing Associate information

What is a biopharmaceutical manufacturing associate?

As a biopharmaceutical manufacturing associate, your primary responsibilities are to prepare equipment and materials for the production of biopharmaceutical products. Your duties include moving the product, supplies, and inventory to support the manufacturing process and operating devices like autoclaves and washers. You monitor the production and operations, make adjustments to increase efficiency, and ensure that you are meeting all safety regulations. You work with downstream and upstream processes to control quality. You are also in charge of preparing reports and reviewing GMP documents to ensure compliance with laws and industry regulations.

What does a biopharmaceutical manufacturing associate do?

A Biopharmaceutical Manufacturing Associate is responsible for producing biopharmaceutical products such as vaccines, antibodies, or therapeutic proteins under strict regulatory guidelines. Their tasks typically include preparing equipment, monitoring production processes, maintaining sterile environments, and ensuring that all procedures adhere to Good Manufacturing Practices (GMP). They may also be involved in quality control, documentation, and troubleshooting equipment issues. This role is crucial for ensuring the safety, efficacy, and quality of biopharmaceutical products.

What are the key skills and qualifications needed to thrive as a biopharmaceutical manufacturing associate?

To thrive as a Biopharmaceutical Manufacturing Associate, you need a solid background in life sciences or engineering, with knowledge of GMP (Good Manufacturing Practices) and often a relevant bachelor’s degree or associate’s certification. Familiarity with bioprocessing equipment, automation systems like SCADA, and quality control tools is essential. Attention to detail, teamwork, and strong communication skills are crucial soft skills for this role. These competencies ensure the safe, accurate, and compliant production of high-quality biopharmaceutical products.

What are some common challenges faced by biopharmaceutical manufacturing associates, and how can they be addressed?

Biopharmaceutical Manufacturing Associates often encounter challenges such as maintaining strict adherence to Good Manufacturing Practices (GMP) and troubleshooting equipment malfunctions under tight production schedules. To address these challenges, associates are trained extensively on standard operating procedures and cross-functional communication to quickly resolve issues. Teamwork and attention to detail are essential, as the role frequently involves collaborating with quality assurance, engineering, and process development teams to ensure product safety and compliance. Continuous learning and proactive problem-solving are key to success in this dynamic environment.

What is the difference between Biopharmaceutical Manufacturing Associate vs Quality Control Technician?

AspectBiopharmaceutical Manufacturing AssociateQuality Control Technician
Primary RoleSupports production processes, prepares materials, and ensures manufacturing runs smoothlyPerforms testing and inspection of products to ensure quality standards
Required SkillsKnowledge of GMP, aseptic techniques, and manufacturing proceduresLaboratory skills, attention to detail, knowledge of testing methods
Work EnvironmentCleanrooms, manufacturing floors, production facilitiesLaboratories, testing labs, quality control areas
CertificationsGMP training, sometimes cGMP certificationLab safety, GMP, and quality assurance training

The Biopharmaceutical Manufacturing Associate focuses on supporting the production process in manufacturing environments, while the Quality Control Technician specializes in testing and verifying product quality. Both roles require GMP knowledge and work in regulated settings, but their daily tasks and skill sets differ significantly.

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The top searched job categories for Biopharmaceutical Manufacturing Associate jobs in Puerto Rico are:

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Cities in Puerto Rico with the most Biopharmaceutical Manufacturing Associate job openings:

Biopharmaceutical Manufacturing Associate jobs near you
Infographic showing various Biopharmaceutical Manufacturing Associate job openings in Puerto Rico as of August 2026, with employment types broken down into 1% As Needed, 71% Full Time, 25% Part Time, 2% Temporary, and 1% Contract. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution.

Specialist Manufacturing

BioPharma Consulting JAD Group

Juncos, PR • On-site

Full-time

Re-posted 29 days ago

Job description

With minimal supervision, the Specialist Manufacturing supports the execution of key manufacturing and quality systems, including non‑conformances, process validation, procedures, training, and new product introductions. The role applies process, operational, and scientific expertise—along with compliance knowledge, analytical skills, and troubleshooting capabilities—to ensure robust and compliant manufacturing operations. The Specialist may serve as a primary process owner for designated production support systems and contribute to process ownership responsibilities for more complex systems.

FUNCTIONS

  • Initiate, revise, and approve manufacturing procedures; serve as document owner ensuring procedures reflect current operations.
  • Assess process performance through floor observation and data review; identify, plan, and implement process improvement opportunities.
  • Provide troubleshooting support for manufacturing operations.
  • Assist in generating training materials and deliver training on scientific or technical aspects of the process.
  • Provide commercial support and floor troubleshooting during campaigns as needed.
  • Support establishment of process monitoring parameters and control limits.
  • Collect and analyze process‑monitoring data; support deviation assessments.
  • Contribute to timely execution of quarterly process monitoring reports.
  • Ensure timely triage of non‑conformances within established goals.
  • Author investigation reports and execute corrective actions.
  • Manage NC/CAPA closure within required timelines.
  • Monitor, communicate, and evaluate incident trends.
  • Review equipment/system Root Cause Analysis investigations and support trend evaluations.
  • Complete CAPA applicability assessments from other sites.
  • Assist in generating validation protocols and reports.
  • Support execution of process validation activities.
  • Collect, analyze, and interpret validation data.
  • Participate in regulatory inspections, New Product Introductions (NPI), and process/equipment modifications.
  • Assess documentation, materials, training, and equipment requirements for NPIs.
  • Provide project management support for process or equipment modification initiatives.
  • Support risk assessments and microbial evaluation exercises.
  • Assist manufacturing change owners with CCRB packages impacting the process.
  • Own change controls for manufacturing process changes.
  • Support Master Batch Record (MBR) creation and revisions.
  • Complete assessments for new or modified Bills of Materials (BOMs).
  • Participate in special projects, automation improvements, and equipment modification assessments.
  • Design, coordinate, and support execution of functional tests, water tests, and other challenge runs during major changes or campaign readiness.
  • Serve as a peer‑recognized specialist in at least one technical area, determining methodologies and best practices.

COMPETENCIES & SKILLS

  • Detailed technical understanding of bioprocessing unit operations (Cell Culture, Drug Substance Purification).
  • Skilled in GMP production operations.
  • Strong regulatory knowledge and experience interacting with regulatory bodies.
  • Ability to lead and participate in cross‑functional teams.
  • Strong communication and collaboration skills with manufacturing, process development, and quality teams.
  • Excellent organizational, technical writing, and presentation abilities.
  • Basic project management skills.
  • Knowledge of control charting and process monitoring methodologies.
  • Proficiency in GDP (Good Documentation Practices).
  • Strong troubleshooting and analytical skills.

TECHNICAL SYSTEMS EXPERIENCE

  • TrackWise
  • VEEVA
  • MES
  • Spotfire
  • CDOCS
  • SmartSheet
  • Power BI
  • Process monitoring platforms
  • ChatGPT / Copilot (for documentation and analysis support)

Requirements

EDUCATION REQUIREMENTS

  • Doctorate OR
  • Master’s + 2 years of Manufacturing Operations experience OR
  • Bachelor’s + 4 years of Manufacturing Operations experience OR
  • Associate’s + 8 years of Manufacturing Operations experience OR
  • High school/GED + 10 years of Manufacturing Operations experience.

PREFERRED QUALIFICATIONS

  • Educational background in Life Sciences or Engineering.
  • In‑depth experience with bioprocessing unit operations.
  • Expertise in Root Cause Analysis methodologies (Fishbone, Six Boxes, 5 Why’s, Kepner‑Tregoe).
  • Familiarity with Lean Manufacturing practices.
  • Strong bilingual communication skills (English & Spanish).
  • Excellent interpersonal skills and teamwork orientation.
  • Ability to work under minimal supervision, high workload, and pressure.
  • Availability for extended hours, on‑call support, and overtime based on business needs.
  • Experience in deviations management, deviation assessments, and biotech manufacturing environments.

Benefits

SHIFT

  • Standard: Monday–Friday, 8am–5pm
  • Flexibility for overtime, extended hours.
  • 1 year contract