Production Operator

PCI Pharma Services; Dublin; On-site; EUR 32,000 - 42,000; Full time

Job summary

PCI Pharma Services is hiring for a Production Operator on the night shift (Thursday–Saturday, 7pm–7am) to support GMP manufacturing. You will work under supervision to ensure batch output meets the required specification, with emphasis on quality, yield and compliance in a fast-paced production environment.

Responsibilities include documenting materials, sampling and visual inspections, liaising with QA, and maintaining housekeeping and safety procedures.

Qualifications

• Fluent English.

Responsibilities

• Ensure product conforms to approved specification.
• Book in and document all materials required for the batch.
• Carry out sampling tests at the required frequency.
• Perform visual inspections at required frequencies.
• Liaise with QA for area/line clearances and quality issues.
• Approve area/line clearances and pre-production samples as per procedures.
• Collect QC samples per batch packaging record.
• Maintain housekeeping and logbooks; ensure logs are up to date.
• Report deviations to supervisor; monitor yields vs. goals and take corrective actions.
• Address machine downtime promptly; achieve training plan competency.
• Ensure batch packaging records are completed accurately and timely.
• Record quantities of good and rejects accurately.

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.

Shift information: Thursday-Saturday nights (7pm - 7am)

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.

Essential

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

Knowledge / Skills & Experience

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 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.