Validation Technician

PCI Pharma Services; Dundalk (MD); On-site; USD 50,000 - 65,000; Full time

Job summary

PCI Pharma Services is seeking an Entry Level Validation Technician to support validation activities related to Process, Facility, and Equipment Development. The role involves ensuring compliance with regulatory standards and collaborating with various teams to maintain documentation and improve processes. Join us to make an impact in the pharmaceutical industry.

Qualifications

• Degree and/or relevant experience required.

Responsibilities

• Assist in ensuring all validation activities meet client expectations and regulatory standards.
• Support compliance with the Site Validation Master Plan.
• Help prepare validation protocols and maintain documentation.

Skills

Adaptability

Passion for Results

Education

Degree and/or relevant experience

Job description

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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.

Description

The Validation Technician role focuses on supporting the implementation and execution of tasks related to Process, Facility, and Equipment Development at PCI Pharma Services sites. This includes participation in various validation areas such as:

• Process Validation (PV)
• Cleaning Validation (CV)
• Computer Systems Validation (CSV)

Responsibilities

• Assist in ensuring all validation activities related to Facility, Equipment, and Processes meet client expectations and regulatory standards (HPRA/FDA).
• Support compliance with the Site Validation Master Plan.
• Help prepare validation protocols for new and existing computer systems, facilities, equipment, and processes. Assist in reviewing and approving reports, and maintaining documentation for cleaning validation at PCI sites in Ireland.
• Participate in validation activities under guidance, collaborating with Technical, Production, and Engineering teams.
• Assist in sampling for validation studies, including AQL and cleaning validation.
• Support management of tooling validations and documentation maintenance.
• Ensure validation procedures are followed, contributing to accurate and timely validation documentation.
• Assist in investigations related to complaints, deviations, and change controls.
• Manage specific or ad hoc projects as required by business needs, within the technician’s capabilities.
• Identify and support process and procedure improvements.
• Participate in periodic reviews and revalidations according to schedule.
• Collaborate with the Validation team to maintain a robust and compliant validation framework.
• Ensure validation activities align with industry standards and regulatory guidelines.

Requirements

• Degree and/or relevant experience

Skills

• Adaptability: Ability to work in a fast-paced, dynamic environment and adjust to unexpected constraints.
• Passion for Results: Drive, high energy, maturity, ability to work under pressure, and deliver results; action-oriented; overcoming obstacles.

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

Equal Employment Opportunity (EEO) Statement

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

At PCI, equity and inclusion are core to our purpose: delivering life-changing therapies. We are committed to fostering an inclusive workplace through accountability, understanding, fairness, respect, and equal opportunity. We aim for a community where everyone belongs and grows, continually assessing our practices, policies, and culture.

Additional Information

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Management and Manufacturing
• Industries: Pharmaceutical Manufacturing

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