Senior Validation Engineer

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

• Sektor Privat

Lead analytical method transfer, validation, and implementation within the QC Chemistry Laboratory, ensuring compliance and quality.

• Degree in Chemistry, Pharmacy, Biotechnology, Microbiology, or related field
• Several years of experience in analytical method development and validation in pharma or biotech
• Experience with multiple analytical techniques
• Knowledge of USP and Ph. Eur. is an advantage
• Familiarity with ICH Q2 (R2), ICH Q14, and EU GMP Annex 1 is beneficial
• Work with advanced pharmaceutical manufacturing technologies
• International work environment with global customers and partners

Senior QC Validation Engineer - Analytical Methods & GMP Compliance

Are you an experienced validation professional looking to work in a highly regulated and advanced pharmaceutical environment?

At Halden Pharma, we are strengthening our QC Validation and Compliance team and are now looking for a Senior Validation Engineer / Specialist to play a key role in ensuring quality, compliance, and robustness of our analytical methods.

This is a unique opportunity to join a specialized pharmaceutical manufacturing company where you will work closely with experts across QC, QA and production - and contribute directly to delivering medicines to patients.

About the role:

In this position, you will support the team within analytical method validation and play a central role in method transfers, implementation, and lifecycle management.

You will work in a dynamic environment with a high level of cross-functional collaboration and exposure to both internal stakeholders and external partners.

Key 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

Who we are looking for:

We are looking for someone who combines strong technical expertise with a pragmatic and collaborative mindset.

Qualifications:

• Bachelor’s or master’s degree (or equivalent) in Chemistry, Pharmacy, Biotechnology, Microbiology or another related field
• Several years of relevant professional experience in analytical method development, optimization, and validation within biotechnology, life sciences, diagnostics, pharmaceuticals, or a related field.
• Experience with multiple analytical techniques
• Knowledge of USP and Ph. Eur. is an advantage
• Familiarity with regulatory guidelines such as ICH Q2 (R2), ICH Q14 and EU GMP Annex 1 are beneficial
• Structured and quality-focused, with the ability to manage complex tasks
• Proactive and solution-oriented, with a drive to deliver results
• Strong collaboration skills and ability to work across functions and cultures
• Clear and confident communicator in English (written and verbal)
• Takes ownership and demonstrates sound judgment within area of expertise

Why join Halden Pharma?

• Work in a highly competent and collaborative environment
• Being part of a company with advanced manufacturing technologies and strong growth ambitions
• Opportunity to influence and shape validation practices in a regulated setting
• International work environment with exposure to global customers and partners
• GMP (Good Manufacturing Practice)
• Kjemi

Halden Pharma is a specialized pharmaceutical manufacturing company with advanced manufacturing technologies and strong growth ambitions. The company operates in a highly regulated and advanced pharmaceutical environment, emphasizing quality, compliance, and robustness in its processes. Halden Pharma fosters a highly competent and collaborative international work environment with exposure to global customers and partners.

LK
Laima Kasiulis
QC Manager
46 62 56 53