Senior Validation Engineer - GMP & Method Transfer

HP HALDEN PHARMA AS; Halden; On-site; NOK 900,000 - 1,200,000; Full time

Job summary

Halden Pharma is seeking a Senior QC Validation Engineer to lead analytical method validation, transfers and lifecycle management in a GMP-regulated environment. You will collaborate across QC, QA and production and ensure robustness of analytical methods.

You will work with external labs, ensure pharmacopeia updates, author and review methods and documentation, and represent the department in audits with global partners.

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Pharmacy, Biotechnology, Microbiology or related field.
• Several years of experience in analytical method development and validation in pharma/biotech.
• Experience with multiple analytical techniques.

Responsibilities

• Lead method transfer, validation, verification and implementation within the QC Chemistry Laboratory.
• Author, review and approve analytical methods and related documentation.
• Collaborate with external laboratories, including contract setup and approval of transfer protocols and reports.
• Prepare and approve key quality documentation (SOPs, protocols, reports, risk assessments, specifications).
• Ensure timely implementation of pharmacopeia updates and verification of compendial methods.
• Support organization within analytical validation field providing scientific and regulatory expertise.
• Execute change control, handle deviations and drive CAPA processes in line with the Quality Management System.
• Represent the department in audits and interactions with customers and regulatory authorities.

Skills

Analytical method development

Validation

Cross-functional collaboration

English communication

Education

Bachelor’s or Master’s in Chemistry/Pharmacy/Biotechnology/Microbiology

Job description

Halden Pharma is seeking a Senior QC Validation Engineer to lead analytical method validation, transfers and lifecycle management in a GMP-regulated environment. You will collaborate across QC, QA and production and ensure robustness of analytical methods.

You will work with external labs, ensure pharmacopeia updates, author and review methods and documentation, and represent the department in audits with global partners.