Parenteral Manufacturing Technician

Pinnaql; Manatí (PR); On-site; USD 42,000 - 65,000; Full time

Job summary

Pinnaql is seeking a dedicated manufacturing technician to join our sterile parenteral operations team in Puerto Rico. You will operate and support aseptic filling processes, follow cGMP and EHS practices, and maintain precise batch records.

Strong attention to detail and the ability to work with automated equipment are essential. Responsibilities include equipment setup, line clearance, data entry into digital batch systems, and adherence to safe, compliant manufacturing procedures on rotating

Qualifications

• High school diploma or equivalent required.
• Minimum of two (2) years of experience in parenteral/aseptic manufacturing, or three (3) years of experience in pharmaceutical manufacturing.
• Experience interacting with automated or computer-controlled production equipment in a regulated environment preferred.
• Prior exposure to formulation, preparation or sterile filling operations is strongly preferred.

Responsibilities

• Operate and support sterile parenteral manufacturing processes in a regulated environment.
• Follow SOPs, cGMP, EHS guidelines, and maintain accurate documentation and batch records.
• Set up equipment, perform line clearances and routine checks.
• Enter data into digital batch records and monitor equipment alarms and process parameters.

Skills

Parenteral manufacturing

Aseptic processing

Regulated environment

Documentation

Education

High school diploma

Tools

PLC-controlled equipment

Job description

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Qualifications and Required Knowledge/Skills

Education and Experience

• High school diploma or equivalent required.
• Minimum of two (2) years of experience in parenteral/aseptic manufacturing, or three (3) years of experience in pharmaceutical manufacturing.
• Experience interacting with automated or computer-controlled production equipment in a regulated environment preferred.
• Prior exposure to formulation, preparation or sterile filling operations is strongly preferred.

Technical and Process Knowledge

• Knowledge of preparation, formulation and aseptic filling processes, including critical process parameters and their impact on product quality.
• Understanding of equipment setup, operation and teardown following SOPs, with the ability to perform setups consistently and accurately.
• Knowledge of sterilization and contamination-control technologies, including steam sterilization, depyrogenation, sterile filtration, lyophilization and isolator technology.
• Ability to execute filter integrity testing and SIP/CIP processes, and to perform basic troubleshooting of mechanical or process issues.
• Knowledge of cGMP, aseptic technique, environmental control, documentation, EHS and hygiene practices within a sterile manufacturing environment.

Digital and Systems Skills

• Basic proficiency operating computerized and PLC-controlled equipment and following digital workflows.
• Ability to navigate manufacturing systems (HMI, handheld devices or digital batch record platforms) and perform accurate data entry and system transactions.
• Ability to interpret electronic data, alarms and system prompts and escape appropriately.

Behavioral and Work Skills

• Ability to work independently and with minimal supervision, following established procedures and maintaining accuracy in all operational and documentation tasks.
• Strong attention to detail, ensuring precision in manufacturing activities, completion of records in alignment with GDP, and adherence to production schedules and operational priorities.
• Effective communication and collaboration skills, with the ability to work constructively within diverse teams and support cross-functional operations.
• Critical thinking and problem-solving skills to effectively address process challenges and adapt to evolving operational needs.
• Ability to train peers and new employees, delivering both theoretical and on-the-job training.
• Flexibility to work rotating shifts, irregular hours, weekends and holidays, as required by production demands.
• Demonstrated accountability, reliability and ownership, upholding high standards for quality, safety, housekeeping and proper waste handling per procedures and EHS requirements.
• Ability to read and interpret procedures, batch records and documentation in English and/or Spanish.
• Strong initiative and adaptability to learn new equipment, procedural updates and emerging technologies.
• Strong organizational and prioritization skills to effectively manage multiple tasks in a fast-paced manufacturing environment.

Working Conditions

• Possible exposure to hazardous chemical substances during routine plant activities; appropriate PPE and training are required.
• Must be fully trained in waste-management and disposal procedures following EHS guidelines.
• Routine use of PPE such as hair covers, gloves, coveralls, respirators, air hoods, ear protection and helmets, depending on assigned area.
• Must be able to perform aseptic gowning and sterile entry procedures, wear sterile gowns, masks, gloves and other required PPE when entering classified areas, and comply with medical surveillance requirements.

Physical Demands

• Routine physical activity is required for equipment operation, material handling and work inside controlled environments. Tasks involve light-to-moderate manual effort (typically 5–60 lbs), depending on the assignment.
• Frequent standing and walking (50–90% of the shift, with approximately 10% sitting), with occasional bending, reaching and extended standing during equipment monitoring, loading/unloading or cleaning activities.
• Performs equipment adjustments, handling of tools and components, and manipulation of parts, requiring fine motor skills, hand-eye coordination and safe body mechanics. Performs setup and operational tasks using glove ports in isolators.
• Uses digital interfaces, keyboards, HMIs and control screens frequently for data entry, equipment monitoring and GDP-compliant documentation.
• Must safely lift, carry, push or pull materials or equipment in the 25–60 lb range as needed, and operate basic material handling equipment such as pallet jacks (occasional use).
• May climb stairs or equipment platforms occasionally to access upper-level components.

Mental and Visual Demands

• Requires steady attention to detail during routine manufacturing tasks such as equipment setup, monitoring processes and completing documentation.
• Must maintain awareness of process conditions, noticing alarms, unusual readings or equipment irregularities and escalating them promptly.
• Requires regular use of digital systems and control screens, needing accurate visual checks and basic interpretation of displayed information.
• Must stay focused during repetitive tasks and when working inside controlled areas or around production equipment.
• Requires the ability to remain calm and attentive when unexpected situations arise, such as abnormal process conditions or minor deviations.

Schedule Shifts: Must be available to work rotating shifts, irregular hours, weekends and holidays, depending on operational needs.

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.