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

Personal qualities

• 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

Om bedriften

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.