Production Technician

About the role

The position is for the night shift, with hours from 6:00 p.m. to 6:30 a.m. the next day, operating on a 12-hour rotating shift. The shift pattern is two days on, two days off, with every other weekend being a three-day work weekend (Friday evening to Monday morning). There is only one position open for this role.

Responsibilities

• Spend most time on the shop floor executing assigned tasks under supervision while learning and applying cGMP, quality and SHE requirements
• Equipment setup/takedown, cleaning, and routine maintenance
• Completing electronic and paper records (MES)
• Escalating deviations
• Supporting area ownership and participating in basic continuous improvement activities
• Follow SOP procedures for equipment setup in a clean room environment, including proper gowning and aseptic techniques
• Use a human-machine interface (HMI) to control processes, especially in purification, formulation, and column packing, with initial assignments typically in purification
• Read procedures, tank setups, follow parameters, escalate issues as needed, and execute column chromatography
• Participate in initial qualification and on-the-job training programs
• Support area housekeeping and DAO standards
• Other duties as assigned

Qualifications

• High school diploma or equivalent required
• 0-1 year relevant experience
• Basic computer literacy
• Willingness to learn MES and CMMS
• Ability to follow instructions and work reliably in a cGMP environment
• BS/BA degree desirable
• A science background, particularly in biochemistry, is very helpful
• Candidates straight out of college are considered, but purely engineering backgrounds are less preferred due to retention concerns

Technical Skills

• Production Knowledge, Process Execution, Quality, and Safety Health & Environment Basic: Demonstrates foundational understanding of SOPs, process flows and critical operational parameters; recognizes upstream/downstream dependencies and impacts
• Process Execution & Documentation: Executes routine production tasks (solution prep, basic cell culture/support tasks, formulation and housekeeping) per SOPs, MPRs and SPRs; completes accurate records in MES to ensure traceability
• Equipment Operation & Maintenance Support: Supports setup, takedown, cleaning and routine maintenance of equipment under supervision; follows qualification requirements and escalation pathways
• Quality, SHE & Risk Awareness: Learns and follows GMP, Quality and SHE protocols; identifies and reports unsafe conditions and quality deviations; participates in safety/investigation activities as required
• Area Ownership & Lean Fundamentals: Supports designated area ownership standards and basic lean practices to maintain a safe, orderly work area and improve local efficiency

Business Skills

• Data Awareness: Uses available data and MES outputs to complete assigned work; records observations and flags anomalies for review
• Digital Familiarity: Embraces and learns digital tools used in the area; participates in digital adoption and training activities
• Work Planning & Execution: Manages and prioritizes assigned daily tasks with supervision; completes work on time with attention to detail and communicates status proactively

People Skills

• Communication: Communicates clearly and concisely with peers and Managers; shares updates and escalations in a timely manner
• Adaptability & Learning: Applies coaching to improve performance
• Leading Self: Takes responsibility for completing assigned tasks, follows instructions, and complies with Company values and safety requirements

Team environment

The team consists of approximately 11 people and values collaboration, eagerness to learn, humility, and an acquisitive mindset.

Pay & schedule

• Pay: $29.22 per hour
• Duration: 6 months
• Shift: Nights, 6pm-6:30 AM, 12-hour rotating shifts (2 days on, 2 days off; every other weekend)
• Location: Frederick, MD