Senior QC Validation Engineer - Analytical Methods \& GMP Compliance
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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:
Who we are looking for:
We are looking for someone who combines strong technical expertise with a pragmatic and collaborative mindset.
Qualifications:
Personal qualities:
Why join Halden Pharma?
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.
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.