Manufacturing Specialist Jobs

About The Position

Requirements

• 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.
• 2+ years of GMP manufacturing experience, preferably in sterile pharmaceutical, biotechnology, fill-finish, combination-product, or similarly regulated operations.
• 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 <790>, <1790>
• 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.
• 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.

Nice To Haves

• Relevant technical certificate or associate degree preferred.

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.
• 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.