Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, the United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Flexible hours/shifts based on business needs
Position Overview
We are seeking an experienced Parenteral Manufacturing Technician to support pharmaceutical and biologics manufacturing operations within a regulated sterile manufacturing environment. The selected candidate will be responsible for executing routine and critical manufacturing activities associated with pharmaceutical formulation, preparation, filling, and lyophilization processes, as applicable to the assigned production area. Responsibilities include equipment setup and operation, cleaning and sanitization, material handling, excipient weighing, aseptic processing, in-process monitoring, and manufacturing documentation. The technician must ensure all activities comply with approved Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), Data Integrity principles, and Environmental Health and Safety (EHS) requirements.
Required Qualifications
- High school diploma or equivalent required.
- Minimum of two (2) years of experience in parenteral or aseptic manufacturing, or three (3) years of experience in pharmaceutical manufacturing.
- Hands-on experience in pharmaceutical manufacturing operations within a regulated GMP environment.
- Knowledge of formulation, preparation, filling, and sterile manufacturing processes.
- Understanding of equipment setup, operation, cleaning, and teardown procedures.
- Knowledge of cGMP regulations, Good Documentation Practices, aseptic techniques, and contamination-control practices.
- Experience handling pharmaceutical raw materials, excipients, and manufacturing components.
- Familiarity with sterilization processes, autoclaves, sterile filtration, and cleaning procedures.
- Ability to perform CIP/SIP operations and filter integrity testing, as applicable.
- Basic troubleshooting skills for manufacturing equipment and process-related issues.
- Basic computer skills and ability to operate automated or PLC-controlled manufacturing equipment.
- Ability to use manufacturing systems, Human-Machine Interfaces (HMI), electronic batch records, and digital production platforms.
- Strong attention to detail and ability to accurately complete manufacturing documentation.
- Ability to read, interpret, and execute manufacturing procedures and batch records in English and/or Spanish.
- Strong communication, teamwork, organizational, and problem-solving skills.
- Ability to work independently with minimal supervision while following established procedures.
Preferred Qualifications
- Direct experience in sterile parenteral or biologics manufacturing.
- Experience with pharmaceutical formulation and sterile filling operations.
- Familiarity with lyophilization processes and equipment.
- Experience operating isolators and working in classified cleanroom environments.
- Knowledge of steam sterilization, depyrogenation, and sterile filtration technologies.
- Experience with CIP/SIP systems and filter integrity testing.
- Familiarity with Environmental Monitoring programs and aseptic processing requirements.
- Experience with automated manufacturing equipment, PLC systems, and electronic batch record platforms.
- Previous experience supporting process validation, equipment qualification, and manufacturing investigations.
- Experience training or mentoring manufacturing personnel.
Key Responsibilities
Parenteral Manufacturing Operations
- Execute pharmaceutical manufacturing activities associated with formulation, preparation, filling, and lyophilization processes, as applicable.
- Perform equipment setup, changeover, cleaning, sanitization, sterilization, and line clearance according to approved procedures.
- Operate manufacturing equipment, including formulation tanks, filling systems, autoclaves, isolators, and associated processing equipment.
- Perform Cleaning-in-Place (CIP) and Sterilization-in-Place (SIP) operations.
- Execute sterilization cycles and pre- and post-use filter integrity testing.
- Receive, verify, handle, and weigh excipients, raw materials, and active pharmaceutical ingredients for manufacturing operations.
- Execute formulation activities, including mixing, pH adjustments, volume adjustments, yield calculations, and in-process controls.
- Collect in-process samples using approved aseptic sampling techniques.
- Monitor manufacturing parameters and equipment performance, performing basic troubleshooting and escalating abnormalities when necessary.
- Operate automated and computer-controlled manufacturing equipment while maintaining Data Integrity requirements.
Documentation, Compliance & Process Control
- Complete manufacturing batch records, logbooks, and electronic transactions accurately, legibly, and contemporaneously in accordance with Good Documentation Practices (GDP).
- Verify the accuracy and completeness of production documentation and associated computerized records.
- Maintain accurate inventory and traceability of manufacturing materials, components, and products.
- Ensure equipment is properly cleaned, labeled, calibrated, and qualified before use.
- Perform batch record reviews and documentation checks as required.
- Identify opportunities for procedural improvements and support the development or revision of manufacturing SOPs.
- Maintain compliance with cGMP, Data Integrity, aseptic processing, and contamination-control requirements.
Quality & Operational Support
- Participate in quality investigations and provide technical input and supporting documentation when required.
- Support equipment qualification, process validation, and manufacturing readiness activities.
- Perform Environmental Monitoring (EM) sampling activities according to approved procedures.
- Support annual equipment and area requalification programs.
- Participate in internal, external, and regulatory inspections.
- Assist with onboarding and on-the-job training of manufacturing personnel.
- Coordinate with Quality Assurance, Validation, Engineering, Maintenance, and other support departments to resolve operational issues.
- Communicate manufacturing status, documentation requirements, and outstanding activities to supervision.
- Provide support to other manufacturing areas based on operational requirements.
Safety & Environmental Compliance
- Maintain clean, organized, and controlled manufacturing areas in accordance with established housekeeping and contamination-control practices.
- Follow all applicable EHS, chemical handling, waste management, and personal protective equipment (PPE) requirements.
- Identify and promptly report potential safety hazards, process abnormalities, and quality concerns.
- Maintain compliance with required GMP, aseptic processing, safety, and environmental training.
Key Deliverables
The selected resource will be responsible for executing and maintaining:
- Pharmaceutical formulation, preparation, and filling operations.
- Equipment setup, changeover, cleaning, sanitization, and sterilization records.
- CIP/SIP operations and filter integrity testing documentation.
- Raw material, excipient weighing, and material reconciliation records.
- Manufacturing batch records and electronic production transactions.
- In-process sampling and process monitoring documentation.
- Environmental Monitoring sampling records.
- Equipment operation, cleaning, and status verification records.
- Manufacturing deviation and investigation supporting documentation.
- Validation, qualification, and annual requalification supporting records.
- Training and qualification documentation for assigned manufacturing activities.
Additional Requirements
- Must complete all required site-specific, cGMP, EHS, and aseptic manufacturing training before performing assigned activities.
- Must maintain current training and qualification status throughout the assignment.
- Must be flexible to work rotating shifts, weekends, holidays, and irregular hours based on manufacturing requirements.
- Must be able to work in controlled cleanroom environments and perform required aseptic gowning procedures.
- Must wear assigned PPE and follow applicable chemical handling, environmental, and waste disposal procedures.
- Must be physically capable of performing routine manufacturing activities, including prolonged standing and walking, equipment operation, and material handling (typically 5–60 lbs, depending on assignment).
- Must promptly communicate and escalate equipment malfunctions, process deviations, safety concerns, and product quality issues.
- Must demonstrate accountability, reliability, and adherence to manufacturing schedules and operational priorities.