Lab Technician - II

Merck & Co.; Pearl River (NY); On-site; USD 65,000 - 90,000; Full time

Job summary

Merck & Co. is seeking a manufacturing operator who will execute production activities, operate process equipment, and support qualification and transfer activities in a regulated environment.

The role requires knowledge of manufacturing operations, adherence to SOPs and cGMP, strong organization, and solid technical documentation skills. Collaboration with cross-functional teams and continuous improvement initiatives are part of daily work.

Qualifications

• Knowledge of process equipment and manufacturing operations.
• Ability to follow SOPs and regulatory guidelines.
• Basic understanding of Current Good Manufacturing Practices (cGMP).
• Strong organizational skills to manage tasks and deadlines.
• Technical documentation skills for production approvals.

Responsibilities

• Execute production activities using knowledge of process equipment, systems, and manufacturing operations.
• Participate in operational qualification training and assist Team Lead as needed.
• Ensure activities comply with policies, SOPs, Values, and regulatory guidelines.
• Work in a structured environment using established procedures.
• Assist in troubleshooting, tech transfer, and start-up activities; apply analytical tools to improve cycle times.

Skills

Process equipment knowledge

Manufacturing operations

Regulatory compliance

Analytical/problem-solving

Documentation skills

Education

Bachelor's or equivalent in science/engineering

Associate's degree +4 years experience

High school diploma +6 years experience

Job description

Job description:
What You Will Achieve
You will have knowledge of process equipment and systems and manufacturing operations with the primary responsibility to execute process and equipment operation activities during manufacturing operations. Due to your expertise in the manufacturing domain, you may participate in training for operational qualifications and assist the Team Lead or other team members as needed. You will conduct all activities in accordance with Company policies and standard operating procedures, *** Values, and global regulatory guidelines, environmental guidelines etc.

• Execute production activities using knowledge of process equipment, systems, and manufacturing operations.
• Participate in operational qualification training and assist the Team Lead as needed.
• Ensure all activities comply with Company policies, standard operating procedures, *** Values, and global regulatory and environmental guidelines.
• Work in a structured environment using established procedures.
• Ensure work is regularly reviewed for technical judgment, completeness, and accuracy.
• Assist in troubleshooting, technology transfer, and start-up activities. Applies established analytical tools to reduce cycle times and optimize production scheduling.
• Oversee technical documentation for production and process approvals, ensuring compliance with Current Good Manufacturing Practices, and manage process activities by adhering to Standard Operating Procedures.
• Assists production teams with batch paperwork and performs system transactions.
• Monitors and communicates production metrics.
• Ensures compliance with all government and company regulatory requirements.
• Verifies batch reconciliation and investigates all discrepancies immediately. Prepares Manufacturing Discrepancy Reports, as necessary, and escalates issues requiring Management Investigation Reports (MIRs) regarding deviations in process tasks or equipment set-up and testing. Partners with the Quality, Technology and Operations personnel to investigate Manufacturing Incidents applying tools as CAPA to eliminate root cause in investigating.
• Participates in continuous improvement initiatives, applying tools like LEAN manufacturing and Six Sigma to improve quality, cost, safety and cycle time.
• Able to handle routine problems independently. Works with cross-functional experts in solving problems.
• Reviews, updates, and revises SOP's.

Here Is What You Need (Minimum Requirements):

• BA/BS degree in a science/engineering field with any years of experience, or Associate's degree with 4+ years of experience, or high school diploma (or equivalent) with 6+ years of relevant experience
• Knowledge of process equipment and manufacturing operations
• Ability to follow standard operating procedures and regulatory guidelines
• Basic understanding of Current Good Manufacturing Practices
• Strong organizational skills to manage project tasks and meet deadlines
• Technical documentation skills for production and process approvals

Bonus Points If You Have (Preferred Requirements):

• Experience within the pharmaceutical industry
• Familiarity with Six Sigma or other operational excellence programs
• Proficiency in troubleshooting and technology transfer activities
• Strong analytical skills for process monitoring and data analysis
• Excellent communication skills for presenting data in project team meetings
• Strong problem-solving skills