High school diploma or GED with 9+ years of relevant experience, or a BA with 2-4 years in a scientific or technical area.
Preferred technical certificate or associate degree in a relevant field.
At least 2 years of GMP manufacturing experience in sterile pharmaceutical environments or similar regulated fields.
Strong attention to detail with commitment to safety and quality.
Knowledge of sterile drug product manufacturing, cleanroom behavior, and contamination control.
Responsibilities
Execute manufacturing operations per Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP).
Support drug formulation processes including staging, dispensing, and mixing of materials as qualified.
Maintain equipment cleanliness and perform sterilization of product-contact parts as necessary.
Set up and monitor robotic isolators and filling lines, ensuring readiness for operations.
Conduct inspections and document all processes accurately and immediately report quality concerns.
Assist in troubleshooting routine equipment issues and making minor adjustments as needed.
Participate in ongoing training and support newer team members during onboarding.
Benefits
Opportunities for professional development through continuous training and education.
Flexible coverage through cross-training in various manufacturing operations.
Participation in continuous improvement initiatives and projects.
Supportive work environment focused on collaboration and teamwork.
Full Job Description
Position Summary
The Manufacturing Specialist II is an independently qualified operator responsible for executing sterile manufacturing across the complete process train with limited routine supervision. The role maintains flexible coverage through cross-training and supports compliant batch execution from formulation through device assembly.
*This is a 1st Shift role; Monday to Friday from 7:00am to 3:30pm.*
Essential Duties and Responsibilities
Perform assigned operations in accordance with approved SOPs, batch records, work instructions, safety requirements, and cGMP expectations.
Support drug product formulation, including material staging, dispensing support, solution preparation, mixing, sampling, pH adjustment, filtration, and transfer as qualified.
Clean, wash, inspect, assemble, wrap, load, sterilize, unload, and store product-contact change parts and equipment components as qualified.
Set up the robotic isolator and filling line, load components, perform approved pre-use checks, initiate and monitor VHP cycles, and support line clearance and readiness activities as qualified.
Operate and monitor prefilled syringe filling operations, respond to alarms within qualification, perform in-process checks, reconcile components, and document interventions.
Operate automated visual inspection equipment and perform qualified manual visual inspection of AVI ejects in accordance with approved defect standards and inspection procedures.
Operate the auto-injector assembly system, including component loading, recipe verification, in-process checks, reject handling, reconciliation, and line clearance as qualified.
Complete batch records, logbooks, forms, labels, and electronic entries accurately and contemporaneously.
Immediately report safety, quality, equipment, environmental, documentation, and process concerns.
Participate in cleaning, environmental and personnel monitoring support, media fills, validation activities, preventive maintenance support, and continuous improvement activities as assigned.
Independently execute assigned qualified operations and coordinate task sequencing with peers.
Perform routine trouble response, recovery, and minor adjustments within approved procedures and training.
Support onboarding and task demonstration for less-experienced staff when designated.
Quality System and Compliance Responsibilities
Follow approved procedures and maintain good documentation and data integrity practices.
Identify and promptly escalate deviations, atypical conditions, errors, defects, alarms, and potential product-quality risks.
Support investigations, CAPAs, change controls, risk assessments, procedure revisions, and inspection readiness activities at a level appropriate to qualification and experience.
Maintain all required curriculum, gowning, aseptic, equipment, safety, and visual inspection qualifications.
Minimum Qualifications
Education
HS/GED with 9+ years' experience or BA with 2-4 years' experience in a scientific/technical area or the combination equivalent of training and experience.
Relevant technical certificate or associate degree preferred.
Experience
2+ years of GMP manufacturing experience, preferably in sterile pharmaceutical, biotechnology, fill-finish, combination-product, or similarly regulated operations.
Required Knowledge, Skills, and Abilities
Strong attention to detail and commitment to patient safety, product quality, and reliable execution.
Working knowledge of sterile drug product manufacturing, aseptic processing, contamination control, and cleanroom behavior. EU Annex 1, US FDA 21CFR Parts 210/211, USP , ,
Ability to read, understand, and execute technical procedures and batch instructions.
Mechanical aptitude and ability to learn automated equipment, HMIs, alarms, sensors, and basic troubleshooting.
Ability to perform accurate calculations and complete clear, compliant documentation.
Ability to pass a visual acuity check for qualification of visual inspection to meet 20/20 near vision (natural or corrected)
Ability to communicate effectively, work collaboratively, accept coaching, and escalate concerns promptly.
Ability to distinguish relevant defects for visual inspection after successful completion of required qualification and periodic requalification.
Demonstrated independent qualification in designated formulation, component preparation, filling, inspection, and assembly operations.
Physical and Work Environment Requirements
Ability to work in classified cleanroom environments and wear required gowning and personal protective equipment for extended periods.
Ability to stand, walk, reach, bend, and perform repetitive tasks for extended periods.
Ability to lift and move materials within company-defined safe-lifting limits, with assistance or mechanical aids when required.
Ability to work around cleaning agents, sanitizers, disinfectants, and VHP-controlled equipment in accordance with approved safety procedures.
Ability to work the assigned schedule and modified schedules during qualifications, media fills, campaigns, shutdowns, or business-critical events.
The duties and responsibilities described above are not intended to be an exhaustive list. Additional duties may be assigned based on business needs. Reasonable accommodation may be made to enable qualified individuals to perform the essential functions of the position.
