Production Operator - Level 2

PCI Pharma Services; Dundalk; On-site; EUR 27,000 - 38,000; Full time

Job summary

PCI Pharma Services in Dundalk, Ireland, is seeking a production-focused professional to support shift output, quality, and yield in line with GMP requirements.

You will ensure products meet specifications, manage batch materials and documentation, perform sampling and visual inspections, liaise with QA for clearances, and help maintain safety and housekeeping standards. Flexibility to shift changes is required.

Qualifications

• Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
• Fluent English

Responsibilities

• Ensure that all product produced conforms to the approved specification.
• All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.
• Sampling tests are carried out at the required frequency.
• Visual inspections are carried out at required frequencies.
• Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.
• Approval of area / line clearances and pre-production samples as required as per defined procedures.
• QC samples are collected as per the batch packaging record.
• Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.
• Deviations are reported to the immediate supervisor.
• Yields are being monitored versus goals & timely corrective actions are being taken.
• Machine downtime is being actioned in a timely fashion.
• Achieve the desired level of competency as per the relevant training plan.
• Ensure that all batch packaging records are completed accurately in a timely manner.
• Ensure that quantities of good & rejects are accurately recorded.
• Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.
• Work positively with all Team Leaders, Engineers and Packaging Manager at all times.
• Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.
• This role demands flexibility to changes in shift patterns at short notice.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
• Assist in all technical aspects and projects as and when required by the Packaging Manager.

Skills

Fluent English

Job description

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 the requirements of current Good Manufacturing Practice.

Responsibilities:

• Ensure that all product produced conforms to the approved specification.
• All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.
• Sampling tests are carried out at the required frequency.
• Visual inspections are carried out at required frequencies.
• Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.
• Approval of area / line clearances and pre-production samples as required as per defined procedures.
• QC samples are collected as per the batch packaging record.
• Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.
• Deviations are reported to the immediate supervisor.
• Yields are being monitored versus goals & timely corrective actions are being taken.
• Machine downtime is being actioned in a timely fashion.
• Achieve the desired level of competency as per the relevant training plan.
• Ensure that all batch packaging records are completed accurately in a timely manner.
• Ensure that quantities of good & rejects are accurately recorded.
• Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.
• Work positively with all Team Leaders, Engineers and Packaging Manager at all times.
• Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.
• This role demands flexibility to changes in shift patterns at short notice.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
• Assist in all technical aspects and projects as and when required by the Packaging Manager.

Knowledge / Skills & Experience

Essential:

• Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
• Fluent English

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.