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Key Responsibilities and Required Skills for Life Sciences Manufacturing Operator

💰 $50,000 - $85,000

Life SciencesManufacturingOperatorBiotechPharmaceutical

🎯 Role Definition

The Life Sciences Manufacturing Operator is responsible for executing and supporting the production of biologics, sterile drug products, and other life science materials in a regulated GMP/cGMP environment. This role operates manufacturing equipment, follows detailed Standard Operating Procedures (SOPs) and batch records, maintains cleanroom behaviors and aseptic technique, and works cross-functionally with quality, engineering and supply chain teams to meet production schedules and product quality targets. Ideal candidates demonstrate strong attention to detail, safety-first mindset, hands-on technical aptitude, and experience with manufacturing execution systems (MES), LIMS, or SAP.

Keywords: Life Sciences Manufacturing Operator, GMP, cGMP, aseptic technique, sterile filling, cleanroom, biologics, pharmaceutical manufacturing, batch records, SOP compliance, MES, LIMS.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Manufacturing Technician (pharmaceutical/biotech)
  • Aseptic Technician / Cleanroom Operator
  • Quality Control Technician or Lab Support Technician

Advancement To:

  • Senior Manufacturing Operator / Lead Operator
  • Process Technician or Process Development Associate
  • Production Supervisor / Shift Lead
  • Validation Specialist or Manufacturing Engineer

Lateral Moves:

  • Quality Assurance (Batch Review, Deviations)
  • Environmental Monitoring or Facilities Operations
  • Supply Chain / Materials Management (Inventory, Kitting)

Core Responsibilities

Primary Functions

  • Execute day-to-day production activities for biologics, sterile injectables, or other life sciences products in compliance with cGMP and internal SOPs, ensuring consistent product quality and adherence to batch record instructions.
  • Perform aseptic processing and sterile filling operations (including vial/syringe/ampoule filling and stoppering) using manual, semi-automated, or fully automated equipment while maintaining strict aseptic technique and gowning procedures.
  • Operate, monitor and troubleshoot production equipment (e.g., bioreactors, chromatography skids, filling lines, lyophilizers, filtrations systems) to meet throughput, yield, and quality targets; escalate complex faults to engineering or maintenance.
  • Complete accurate batch records, production logs, and equipment checklists in real-time, documenting deviations, non-conformances and in-process measurements to support traceability and regulatory inspections.
  • Perform routine in-process sampling, measurements and visual inspections; coordinate with Quality Control and analytical labs for timely testing and interpretation of results.
  • Conduct cleanroom gowning, environmental monitoring, and contamination control practices to sustain classified room standards (ISO 5–8); participate in CAPA and environmental trend investigations when anomalies are observed.
  • Support line changeovers, product changeovers and product setups including cleaning-in-place (CIP), sterilization-in-place (SIP), and sterilization cycles for equipment and utilities per validated procedures.
  • Follow and contribute to process validation, revalidation and qualification activities by executing protocols and reporting objective data for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) phases.
  • Implement 5S, Lean manufacturing and continuous improvement recommendations on the shop floor; propose and validate improvements that reduce cycle time, minimize waste and increase first-pass yield.
  • Adhere to safety programs and hazardous material handling requirements (including SDS, PPE use, spill response and safe waste disposal) to maintain a safe production environment.
  • Participate in routine preventative maintenance tasks and basic calibration activities on equipment; prepare detailed maintenance hand-off documentation for engineering teams.
  • Execute material handling, kitting, weighing and component preparation following material control processes to prevent mix-ups and ensure batch integrity.
  • Investigate and document process deviations and non-conformances; support root cause analysis and implementation of corrective and preventive actions (CAPA) with cross-functional stakeholders.
  • Use Manufacturing Execution Systems (MES), LIMS or SAP to enter batch data, track production status, manage inventory and retrieve electronic batch records; ensure data integrity and ALCOA+ principles are observed.
  • Train and mentor new operators and seasonal staff on GMP, aseptic technique, equipment operation and company SOPs; maintain training records and competency assessments.
  • Support sterile filling visual inspection and in-process quality checks to ensure product attributes (fill volume, clarity, particulates) meet acceptance criteria and regulatory requirements.
  • Execute container closure integrity testing and line checks to assure packaging quality, container integrity and minimize risk of contamination or leaks.
  • Coordinate with Quality Assurance for batch release readiness by providing batch documentation and addressing open items or deviations in a timely manner.
  • Participate in change control, deviation investigations and quality review meetings; write clear and factual narrative descriptions of events for audit readiness.
  • Apply basic statistical process control (SPC) metrics and production KPIs to monitor process performance and alert supervisors to trends requiring intervention.
  • Support product stability programs and sample dispatch activities as required, ensuring chain-of-custody and proper sample labeling and storage conditions.
  • Maintain cleanliness and sanitation of production areas, including waste segregation, line sanitation and cleaning validation support as needed.

Secondary Functions

  • Support continuous improvement initiatives by collecting production data, proposing hypotheses and participating in pilot runs for process optimization.
  • Assist Quality and Regulatory teams during internal and external audits by preparing documentation, walking auditors through processes and implementing minor corrective actions.
  • Participate in cross-functional projects such as technology transfers, scale-up activities and new product introductions to ensure smooth manufacturing ramp-up.
  • Help coordinate spare parts, consumables and reagent replenishment to minimize downtime and support on-time delivery targets.
  • Provide input to SOP updates and work instructions based on practical experience and observed process gaps.
  • Serve as a subject matter resource for safe handling and containment of biologically active materials and controlled substances during production.
  • Contribute to operator shift handovers by preparing clear, concise logs and communicating key process or equipment status to incoming teams.
  • Support ad-hoc investigations and special studies (e.g., particulate root cause, environmental excursions) by executing defined tasks and recording objective evidence.

Required Skills & Competencies

Hard Skills (Technical)

  • Strong working knowledge of GMP / cGMP regulations and expectations for pharmaceutical and biotech manufacturing.
  • Aseptic technique and cleanroom behaviors for sterile product manufacturing (ISO classified environments).
  • Hands-on operation and troubleshooting of manufacturing equipment: filling lines, bioreactors, chromatography systems, lyophilizers, filtration skids.
  • Batch record execution, electronic batch record (EBR) systems and familiarity with MES/LIMS/SAP.
  • Experience with CIP/SIP processes, sterilization cycles and basic sterilization qualification principles.
  • In-process testing and sampling, including knowledge of sterility, endotoxin and particle control basics.
  • Container closure integrity awareness and basic inspection techniques for sterile drug products.
  • Documentation excellence: SOP adherence, deviation reporting, CAPA support and accurate record-keeping.
  • Basic instrumentation and calibration knowledge, ability to perform routine checks and report calibration failures.
  • Root cause analysis and problem solving methodologies (5 Whys, fishbone), and participation in CAPA lifecycle.
  • Quality systems literacy: deviations, change control, non-conforming material handling and batch release processes.
  • Familiarity with safety and hazardous material handling procedures relevant to biological agents and chemical reagents.

Soft Skills

  • Exceptional attention to detail and high level of personal accountability for product quality and data integrity.
  • Strong verbal and written communication skills for cross-functional collaboration and documentation.
  • Team-oriented attitude with ability to work effectively in shift-based and fast-paced manufacturing environments.
  • Good troubleshooting mindset, curiosity and persistence to identify practical solutions under time constraints.
  • Adaptability and flexibility to support changing priorities, product introductions and varying schedules.
  • Time management and organizational skills to meet production timelines and training requirements.
  • Continuous improvement mindset with openness to Lean, Six Sigma or process optimization practices.
  • Professionalism and ethical behavior to maintain patient safety focus and regulatory compliance.

Education & Experience

Educational Background

Minimum Education:

  • High school diploma or GED required; vocational/technical certificate or associate degree preferred.

Preferred Education:

  • Associate degree or Bachelor's degree in Life Sciences, Biotechnology, Chemical Engineering, Bioprocessing, Microbiology, or related technical field.

Relevant Fields of Study:

  • Biotechnology
  • Bioprocessing / Biochemical Engineering
  • Microbiology / Biology
  • Chemical Engineering
  • Pharmaceutical Sciences
  • Manufacturing Technology / Industrial Technology

Experience Requirements

Typical Experience Range: 1–5 years of hands-on experience in pharmaceutical, biotech, medical device or sterile manufacturing operations.

Preferred:

  • 2–5+ years operating in a GMP/cGMP regulated production environment, with experience in aseptic processing, sterile filling, or biologics manufacturing.
  • Demonstrated experience with batch record execution, MES/LIMS systems, and working knowledge of regulatory expectations (FDA, EMA).
  • Experience with process validation, change control and participation in audits is advantageous.
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