Validation Team Leader

Overview

Lead equipment & process validation for pharma manufacturing under cGMP.

Requirements

• process validation
• cgmp
• leadership
• mentoring
• tertiary degree
• 8+ yrs

What You Bring

As a preferred candidate, you will need to have a solid base with a minimum of 5 years process and equipment validation experience within pharmaceutical or medical device manufacture. You’ll be able to manage a validation master plan, write, execute and approve validation protocols (IQ, OQ, PQ and well as DQ and SQ if possible), and be fully conversant with regulatory requirements as specified by Medsafe, FDA or similar. You will need to be able to work independently as a subject matter expert but also engage with and support other members of the validation team. You’ll also be adept at working cross-functionally with other teams so as to manage your workload and deadlines alongside theirs for a mutually successful outcome. Our Auckland-based client, an established player in the New Zealand pharmaceutical market, is looking an experienced Validation Engineer with leadership experience for their ever expanding business. With this company manufacturing a large range of products to cGMP standards, and continued capital expansion of their manufacturing plant to meet expected future demand, they have need for professional with validation experience across all fields but with particular focus on equipment and process validation for their utilities and production areas. Reporting to the Validation Manager, this is an important role within the validation team whereby you, the incumbent, will work directly to complete specific routine and new validation projects as well as supporting the junior members of the team as they grow and develop. Scope of the role will cover all aspects of validation within a pharmaceutical manufacturing plant and you will be expected to have experience in this from other cGMP facilities either in NZ or internationally. -Able to support and mentor colleagues -Strong time management skills, able to see and resolve potential issues -8+ years experience in process validation including IQ/OQ/PQ and preferably DQ/SQ -Broader QA and GMP experience within a pharmaceutical (or equivalent) environment -Computer literacy -Tertiary qualification in a relevant scientific field -Proven ability to build and maintain strong cross-functional working relationships -Experience in leading and mentoring others in a cross-functional environment -Experience in a cGMP environment – pharma or medical devices

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Benefits

Our client is a fast paced and supportive business where you are expected to do your bit but in return they offer a competitive salary with benefits, mentored career development and opportunities to work for a highly respected NZ employer. -Opportunity to develop your skills and long term career -Stable employment

About Technical Recruitment Solutions Ltd

-A team of professionals with real-world industry experience blends recruitment expertise with technical insight. -Provides permanent and contract placements across entry-level to executive positions in core sectors. -Operates primarily in civil, construction, food & dairy, industrial & energy, manufacturing & trades, and scientific & pharmaceutical sectors. -Typical projects include filling construction engineering roles, industrial maintenance positions, and QA/QC specialist jobs in the dairy sector. -Maintains a national reach through offices in Auckland and Wellington and taps into global markets when local talent is scarce. -Offers client protection via placement guarantees and competitive fee structures that reflect long-term partnerships. -Has built a reputation as one of New Zealand’s most trusted technical recruitment consultancies.

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