Senior Validation Engineer

Our Validation team is instrumental in ensuring the success of strategic programmes such as new equipment and systems investment, new product commercialisation, cleaning process development and validation, and ongoing process improvements, to ensure we continue to meet our compliance requirements and our own high standards. We are currently looking for a Senior Validation Engineer to act as a technical lead for the validation activities the team is responsible for and/or supports across the business. In this role you will be responsible for supporting the Validation Leadership team in the maintenance of the validation governance, assessing change control notifications, leading/supporting quality investigations, planning, designing, executing, and reporting on lifecycle activities for the following:

• Commissioning and Qualification of Facilities, Utilities, and Production Equipment
• Process Performance Qualification and Continued Process Verification
• Cleaning Process Development and Validation

Not only will the role assist the validation leadership team, and lead validation lifecycle activities, but it is also a role which coaches junior members in the team and looks for continuous improvements in how we conduct our validation activities. Good knowledge and experience of the Pharmaceutical Industry, relevant GMP regulations, and industry best practices is a must. You will have:

• 5+ years' experience working in a GMP environment, and at least 3 years validation experience.
• A strong understanding of the cGMPs (especially EU, US), and knowledge/understanding of industry best practices.
• A track record of critical thinking and ability to apply first principles thinking to complex situations.
• A coach, someone who can develop others technically; capable of providing guidance and developing critical thinking.
• Ability to perform under pressure and deliver to agreed, often tight, deadlines.
• Good communication and interpersonal skills with the ability to inspire others towards a common goal.
• A commitment to self-learning and development, staying current with industry best practices and the latest trends in the industry.
• The ability to translate learnings into practical execution.
• Excellent writing skills with a capability to communicate technical details to a wide and sometimes non-technical audience.

You should also have a degree in Science or Engineering (Chemical, Mechanical, Process or Mechatronics), and have experience working in a compliance driven industry. Are you ready to be part of it? What we offer:

• Career growth - we relentlessly develop our people and promote internally.
• Flexi-work options.
• Regular onsite events to celebrate our diversity.
• Five weeks leave from your sixth anniversary.
• Life and income protection insurance.
• The best Social Club which organises amazing events regularly.
• Discounted products from our consumer and nutraceutical ranges including Clinicians, BraveFace, Bio Oil, Nexcare, to name a few.

About Us: Douglas is one of New Zealand's greatest pharmaceutical success stories with an ever-expanding footprint into global markets. Privately owned, we are working to develop, trial, manufacture, test, pack and distribute the very best medicines, nutraceuticals, and products around the world. At Douglas there are around 650 of us - including top scientists, researchers, manufacturers, regulators, supply chain professionals and engineers, and together we are on a mission to make high quality, effective and accessible products for people who need it. We are helping people with conditions like depression, schizophrenia, breast cancer, heart failure, severe acne, as well as people who need antibiotics and medicines to support their immune system. Next steps: If you are invited to complete a video interview as the next stage of your application, we'd love you to embrace it. Video interviews allow more people the opportunity to demonstrate their abilities to the hiring manager in a new and innovative way, giving you a better chance of securing your ideal role. Relax, be yourself and do not worry, we all feel a bit awkward in front of the camera. Want to be part of a true kiwi success story? Apply today! All applicants must undergo pre-employment screening and background checks. Legitimacy statement: Douglas communicates with candidates over e-mail, phone, LinkedIn and Microsoft Teams and all communications come from Douglas domain names. We do not use technologies like WhatsApp or other consumer social networks or communication tools. If you feel unsure about any communication, you receive from us please email careers@douglas.co.nz and we will verify the legitimacy of the communication.

Job Details:

Reference:

13752

Expertise:

Processes Engineering, Pharmaceuticals, Quality Assurance

Job Level:

Experienced

Location:

West Auckland

Work Type:

Permanent full-time

Application Closes:

15 Jan 2025 23:55

More details (document):

senior validation engineer jd - 06 nov 2022.docx

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