Production Tech & Process Spec II (9095)

Job description

Orion Group Life Sciences are looking for a Production Tech & Process Spec II (Senior Validation Expert) for our Pharmaceutical client based in the Haarlem Area. Initial 12-month contract.

What will you do
A highly skilled and experienced Senior Validation Consultant with expertise in validation/re-qualifications of Equipment/System including Project work/Changes/CAPAs. In addition, knowledge of steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, smoke studies/air flow visualization studies & validation related to within the pharmaceutical industry. You will play a critical role in ensuring compliance with regulatory requirements and industry standards while optimizing operational efficiency and product quality.

Main Responsibilities of the role

• Lead and participate in equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Support execution of validation protocols/plans for Validations/Re-qualifications of steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, smoke studies/air flow visualization studies.
• In case of deviations, Document, notify & co-ordinate for corrective action, and close out.
• Provide technical expertise and guidance on validation-related issues to project teams and stakeholders.
• Collaborate with cross-functional teams to ensure validation activities align with production schedules, project timelines and quality expectations.
• Conduct risk assessments and impact analyses related to validation activities and propose appropriate mitigation strategies.
• Draft, review and assess validation data, deviations, and change controls to ensure compliance with regulatory requirements and the internal quality standards of our client.
• Ensure adherence to Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) during validation activities.
• Support during internal/external inspections/Audits in addition to representing relevant topics as an SME & having solid knowledge to communicate with authorities.
• Mentor and provide training to junior validation team members, sharing knowledge and best practices.

Desired Experience and Background of the successful candidate

• Bachelor's or higher degree in a relevant scientific or engineering discipline.
• Minimum 4-5 years of experience in validation/CQV within the pharmaceutical industry.
• Knowledge of experience in GMP including V-Model & SDLC methodologies.
• Strong analytical, problem-solving, organizational and project management skills.
• Team player with attention to detail and strong can-do mentality.
• Excellent written and verbal communication skills, including the ability to effectively collaborate with multidisciplinary teams.

If you would like to have a confidential conversation regarding this opportunity please reach out to Tim Browaeys, [email protected] or contact Tim on 0044 7593448607

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Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.