IRE_Production Operator - Level 2

PCI TRGR Penn Pharmaceutical Services Ltd; Dundalk (MD); On-site; USD 40,000 - 55,000; Full time

Job summary

A leading company in biopharma is seeking a Production Operator to ensure quality and compliance in manufacturing processes. The role involves monitoring production output, conducting inspections, and adhering to safety procedures. Join us in delivering life-changing therapies to patients.

Qualifications

• Fluent in English.

Responsibilities

• Ensure all produced products conform to approved specifications.
• Book in and document all materials required for the batch accurately.
• Perform visual inspections as required.

Skills

Communication

Job description

IRE_Production Operator - Level 2 page is loaded

IRE_Production Operator - Level 2

Apply locations IRL_Dundalk | Full time | Posted 2 Days Ago | Job requisition id JR114331

Life-changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in people who make an impact, drive progress, and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Role:

Responsible, in conjunction with the immediate supervisor, for shift output, quality, and yield in compliance with current Good Manufacturing Practice requirements.

Responsibilities:

• Ensure all produced products conform to the approved specifications.
• Book in and document all materials required for the batch accurately, conforming to packaging instructions and batch packaging records.
• Carry out sampling tests at the required frequency.
• Perform visual inspections as required.
• Liaise with the QA department for support in area/line clearances and address any quality issues during production.
• Approve area/line clearances and pre-production samples as per procedures.
• Collect QC samples as per batch packaging records.
• Adhere to operating, quality, machine cleaning, and safety procedures.
• Report deviations to the immediate supervisor.
• Monitor yields against goals and implement corrective actions promptly.
• Address machine downtime efficiently.
• Achieve the required competency level as per training plans.
• Complete batch packaging records accurately and promptly.
• Record quantities of good and rejected products accurately.
• Maintain high standards of housekeeping and keep logs updated.
• Work positively with team leaders, engineers, and managers.
• Follow safe work practices and report defects immediately.
• Be flexible to shift pattern changes at short notice.
• Perform additional tasks as required to support company goals.
• Assist with technical projects as needed.

Knowledge / Skills & Experience

Essential:

• Ability to meet goals, communicate clearly, and ensure progress.
• Fluent in English.

Join us and be part of building the bridge between life-changing therapies and patients. Let’s talk future.

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not discriminate unlawfully based on race, color, religion, age, sex, creed, national origin, ancestry, citizenship, marital status, familial status, sexual orientation, gender identity, disability, military status, or any other protected class.

At PCI, Equity and Inclusion are core to our purpose: delivering life-changing therapies. We commit to an inclusive workplace where everyone belongs and can grow, continually assessing our practices and culture.