Technician, Operations (2nd shift) - Oral Solid Dosage / Inhalation

$53,200 - $83,800/Yr

Merck KGaA Darmstadt Germany - Rahway, NJ

Full-time - Entry Level

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The Technician, Operations position in the Pharmaceutical Operations and Clinical Supply team focuses on supporting drug product development and GMP clinical supply of oral solid dosage forms. This role involves hands-on processing activities, including equipment setup, operation, and cleaning, specifically for spray drying production runs. The position requires adherence to GMP procedures and collaboration with various teams to ensure the success of clinical manufacturing processes.

Responsibilities

• Prepares, operates, and cleans equipment and facilities used in clinical development and manufacturing processes.
• Operates Spray Drying system for production runs.
• Executes on assembly and disassembly of equipment for process turnaround.
• Maintains, inventories, and transports required processing equipment, materials, supplies, and products.
• Executes all documentation and clerical functions necessary to maintain good manufacturing practice (GMP) operations, using paper-based and electronic systems.
• Maintains detailed knowledge of process equipment and operations, troubleshooting equipment/systems to resolve issues and aid in technology and process development.
• Attends and actively participates in safety, quality, and process improvement initiatives to enhance flexibility, efficiency, and compliance.
• Supports investigations and implementation of corrective/preventative actions.

Requirements

• High School Diploma/GED or higher.
• 1+ years of relevant GMP Pharmaceutical experience, or equivalent (e.g. chemical, nuclear, military experience).
• Demonstrated written and verbal communication skills.
• Proficiency in computer systems and applications including Microsoft Office (Word, Excel, Outlook), Equipment HMI use, SAP, Calibration/Maintenance Database Systems.
• Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and don & wear cleanroom protective gowning including respirators.
• Demonstrated ability to work and communicate both independently and as a part of a team.

Nice-to-haves

• At least 2 years GMP manufacturing/processing experience.
• Familiarity with regulatory requirements and Good Documentation Practices (GDP).
• Experience with highly complex and state of the art equipment, oral solid dosage, tablet compression, encapsulation, spray drying, film coating, dry powder inhalers, drug product device assembly lines, isolators, containment technology, aseptic filling using automated machinery, sterile manufacturing, visual inspection of product in glass vials, SAP or other ERP systems.
• Associates Degree in science or related field.
• BioWork Certificate (working in an FDA or similar regulated industry).
• Experience with automated systems (MES, SAP, or similar).
• Demonstrated troubleshooting / problem-solving skills.

Benefits

• Bonus eligibility
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days