Manufacturing Operator

Actalent; New Jersey; On-site; USD 42,000 - 62,000; Full time

Job summary

Actalent in New Jersey seeks a Manufacturing Operator to join a fast-paced pharmaceutical operation. You will operate manufacturing equipment, document processes meticulously, and collaborate with quality, maintenance, and development teams to produce clinical supplies and support development experiments.

Responsibilities include following SOPs and GDP, setting up lines, performing changeovers, conducting in-process inspections, and using IT systems for data entry.

Qualifications

• Associates Degree in a scientific discipline, engineering, or related field.
• 2+ years in GMP pharmaceutical manufacturing, R&D, or equipment manufacturing.
• Experience with batch records, QA operations, and line clearance in GMP environments.
• Hands-on experience as a manufacturing operator or packaging technician in regulated settings.
• Strong knowledge of cGMP and its daily application.

Responsibilities

• Train and follow all policies, SOPs, and regulatory requirements.
• Perform pharmaceutical manufacturing activities in a GMP environment with quality and safety standards.
• Execute batch records and maintain GDP, ensuring data is accurate and legible.
• Set up lines, perform changeovers, and operate production equipment per procedures.
• Conduct equipment setup, operation, cleaning, and ensure cleanliness and readiness.
• Use PPE and controls to perform tasks safely per safety policies.
• Conduct in-process inspections and sampling, document results as required.
• Enter data using IT platforms and electronic systems to support manufacturing and quality.
• Support developmental manufacturing experiments and document outcomes.
• Assist with deviations, corrective actions, and continuous improvement initiatives.
• Aid maintenance with preventative maintenance and basic troubleshooting.
• Contribute to continuous improvement and stay current with industry trends.

Skills

GMP experience

Documentation

Equipment operation

SOPs & GDP

Quality compliance

Process improvement

Education

Associate degree in a scientific discipline

Job description

Job Description

Job Title: Manufacturing Operator

Job Description

The Manufacturing Operator works under direct supervision to operate pharmaceutical manufacturing equipment in a cGMP environment, producing clinical supplies and supporting development experiments. This role combines hands‑on equipment operation, meticulous documentation, and collaboration with quality, maintenance, and development teams in a fast‑growing contract manufacturing setting.

Responsibilities

• Train on and consistently follow all applicable policies and procedures, including regulatory requirements, safety guidelines, standard operating procedures (SOPs), work instructions, and related documentation.
• Perform pharmaceutical manufacturing activities in a GMP or other regulated manufacturing environment while maintaining strict compliance with quality and safety standards.
• Execute batch record activities and maintain Good Documentation Practices (GDP), ensuring all manufacturing data, entries, and corrections are accurate, complete, and legible.
• Set up manufacturing lines, perform changeovers, and operate production and packaging equipment according to established procedures.
• Carry out room and equipment setup, operation, and cleaning for pharmaceutical production, ensuring areas and equipment meet cleanliness and readiness requirements.
• Use appropriate personal protective equipment (PPE) and engineering controls to perform all tasks safely and in accordance with safety policies.
• Conduct in-process inspections and sampling to verify product quality and process performance, documenting results as required.
• Use the designated IT platform and computer systems to enter data, complete electronic records, and support manufacturing and quality processes.
• Perform developmental manufacturing experiments under the direction of a formulation specialist or process engineer, following experimental protocols and documenting outcomes.
• Support investigational and quality systems activities, including assisting with deviations, corrective actions, and continuous improvement initiatives.
• Assist maintenance personnel with preventative maintenance activities, basic troubleshooting, and minor repairs of manufacturing equipment as needed.
• Participate actively in continuous improvement activities by suggesting process enhancements, efficiency gains, and quality improvements.
• Remain current with professional and industry trends, incorporating new knowledge into daily work where appropriate.
• Make positive contributions by offering suggestions for improvement and actively learning new skills, procedures, and processes.
• Carry out duties in full compliance with all applicable federal and state regulations, as well as company and site policies and procedures.
• Remain available for additional duties as required to support production schedules and operational needs.
• Be available for overtime as needed to meet production and project timelines.

Essential Skills

• Associates Degree in a scientific discipline, engineering, or a related field.
• At least 2 years of experience in GMP pharmaceutical manufacturing, research and development (R&D), or pharmaceutical equipment manufacturing.
• 2+ years of experience with batch record review, QA operations, and line clearance in a pharmaceutical or CDMO GMP environment.
• Hands‑on experience as a manufacturing operator or packaging technician in a regulated or GMP manufacturing setting.
• Demonstrated experience working within QA and compliance requirements in a pharmaceutical or CDMO production environment.
• Strong knowledge of current Good Manufacturing Practices (cGMP) and their application to daily manufacturing activities.
• Ability to read and interpret standard operating procedures, manuals, batch records, work instructions, and specifications.
• Legible handwriting and the ability to complete detailed written documentation accurately and consistently.
• Clear written and oral communication skills for effective interaction with cross‑functional teams and accurate documentation.
• Proficiency with basic arithmetic, including addition, subtraction, fractions, percentages, ratios, and proportions, and the ability to apply these concepts to practical manufacturing tasks.
• Ability to identify simple and moderate problems related to job functions and elevate or resolve them appropriately.
• Demonstrated deductive reasoning skills to apply general rules to specific problems and produce logical solutions.
• Demonstrated inductive reasoning skills to combine pieces of information and identify patterns, trends, or relationships.
• Ability to perform repetitive tasks while ma