Position Summary:
The Machine Operator I is a member of the Production Team responsible for supporting automated labeling and visual inspection activities within a 503B pharmaceutical manufacturing environment. This role primarily works in a controlled non-classified (CNC) environment and requires employees to follow detailed procedures, wear appropriate PPE, and complete documentation accurately and in real time. This position supports production by setting up, operating, monitoring, and helping troubleshoot automated labeling and visual inspection equipment. The Machine Operator I also supports related activities such as cleaning, restocking, waste destruction, component verification, visual inspection, labeling, and production documentation as required or assigned. This is a strong opportunity for someone who is mechanically inclined, detail-oriented, comfortable working with automated equipment, and motivated to build a career in pharmaceutical manufacturing while supporting patient safety and product quality.
What this role does day to day:
In this role, the Machine Operator I may prepare automated labeling or visual inspection equipment for production by loading recipes, threading labels, performing part changeovers, verifying components, and confirming the line is ready for use. During processing, the role may monitor equipment performance, support production flow, identify equipment or documentation issues, and escalate concerns before they impact quality, safety, or compliance. The role requires careful, consistent work in a regulated environment. Candidates should be comfortable following SOPs and batch records, documenting work accurately, performing repetitive tasks, making minor adjustments to equipment when trained to do so, and communicating with Production, Warehouse, Quality, and leadership as needed to keep operations running safely and compliantly.
Key Responsibilities:
- Perform setup and support functions for automated labeling and visual inspection equipment according to approved procedures, work instructions, batch records, and cGMP requirements.
- Load equipment recipes, thread labels, verify setup steps, and ensure the correct components and supplies are available for production activities.
- Perform part changeovers for automated labeling and visual inspection equipment after required training and qualification.
- Operate, monitor, and support production processing involving visual inspection and labeling equipment.
- Verify that labels, components, product containers, equipment settings, and production documentation align with the assigned process and batch requirements.
- Make minor equipment adjustments to address issues when trained and authorized to do so, and escalate equipment concerns or abnormal conditions appropriately.
- Demonstrate basic troubleshooting skills and collaborate with leadership, maintenance, engineering, quality, warehouse, or other support departments to resolve issues.
- Interface with Warehouse and other support departments to help maintain appropriate levels of production components, materials, and supplies.
- Accurately and contemporaneously document required activities according to GDP/cGMP expectations, including entries in batch records, logs, checklists, or other required documentation.
- Participate in deviation initiation and investigation activities as required or assigned, including providing factual information about what occurred during the process.
- Assist with cleaning, restocking, waste destruction, line clearance, and maintaining CNC production areas as required.
- Perform visual inspection, labeling, packaging, or other production support tasks when required or assigned.
- Follow all PPE, safety, OSHA, EPA, RCRA, DEA, FDA, cGMP, and company policy requirements.
- Recognize and escalate potential deviations, documentation errors, equipment issues, product defects, process concerns, or safety risks before proceeding.
- Maintain a quality-focused, Right First Time mindset and understand the team’s direct impact on product quality and patient safety.
- Communicate effectively across shifts and with cross-functional partners, including Production, Quality, Warehouse, Maintenance, and leadership.
- Support continuous improvement by speaking up when there may be a safer, more compliant, or more efficient way to perform a task.
What Success Looks Like
- Arrives on time and is prepared to work in the CNC environment at the start of the shift.
- Follows SOPs, batch records, equipment setup instructions, line clearance expectations, and work instructions exactly without taking shortcuts.
- Maintains focus and accuracy while setting up, operating, monitoring, inspecting, labeling, documenting, or cleaning equipment and production areas.
- Understands that labels, visual inspection, equipment setup, and documentation directly impact product quality and patient safety.
- Identifies equipment issues, mismatches, documentation concerns, or unexpected conditions and escalates them before proceeding.
- Completes documentation accurately, legibly, and in real time according to GDP/cGMP expectations.
- Works well with others, communicates clearly across shifts and departments, and accepts feedback professionally.
- Demonstrates accountability, integrity, mechanical aptitude, and motivation to learn multiple processes and progress in the role.
Required Qualifications
- High school diploma or equivalent required.
- Prior experience in cGMP, pharmaceutical manufacturing, medical device, regulated manufacturing, packaging, labeling, production, warehouse, or quality-focused work preferred.
- Prior experience operating automated or semi-automated equipment, manufacturing machinery, packaging equipment, labeling equipment, inspection equipment, or similar production equipment preferred.
- Knowledge of FDA-regulated environments, cGMP, GDP, SOPs, work instructions, or batch record documentation preferred.
- Basic arithmetic and measurement skills required; basic chemistry or production-related calculations preferred.
- Must be able to speak, read, and write in English.
- Must have excellent attention to detail and strong written and verbal communication skills.
- Must be comfortable following detailed procedures, completing documentation accurately, and escalating concerns when something does not look right.
- Must be able to work in a fast-paced environment with changing priorities and production demands.
- Must be a team player with accountability, professionalism, leadership potential, and a desire to expand knowledge and grow with the company.
- Must be willing to participate in training, maintain job-task qualifications, and gain additional certifications or qualifications as needed.
Physical Requirements
- Ability to work in a controlled non-classified manufacturing environment while wearing required PPE for most or all of the shift.
- Ability to stand, sit, walk, bend, reach, and perform repetitive tasks for extended periods.
- Ability to lift up to 50 pounds at times and push, pull, move, or handle materials, product containers, pallets, supplies, or equipment as needed.
- Ability to perform detailed work while maintaining focus, accuracy, and procedural discipline.
- Ability to work variable shifts, overtime, weekends, or multi-shift schedules based on business needs.
Work Environment
This position primarily works in a controlled non-classified manufacturing environment. Employees are expected to follow PPE, safety, cleanliness, documentation, equipment-use, and conduct expectations at all times. The role may involve automated labeling and visual inspection equipment, production components, pharmaceutical products, cleaning agents, waste destruction activities, and other production materials, all of which must be handled according to approved procedures and safety requirements.
Benefits:
We offer a comprehensive and competitive benefits package designed to support the health, well-being, and financial security of our employees and their families.
At STAQ Pharma, all full time employees have access to:
- Medical, dental, and vision insurance options
- Employer-paid life insurance and disability coverage
- Employee Assistance Program
- 401(k) retirement plan with employer match
- Paid time off (PTO), sick leave
- 7 paid holidays
- Opportunities for professional growth in a regulated pharmaceutical manufacturing environment
- Employee-focused culture emphasizing safety, quality, and teamwork
The application window for this position is anticipated to be open at least 25 days
10am-6:30pm (or until done)