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:**

– Bachelors or masters 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.

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