API Pharma

Senior Validation Engineer & Validation Manager (GMP/Pharma)

API Pharma

Professional Services

Job listing link
Applications Close - End of Day: 28-08-2020


New Zealand

Work type:

Great opportunity for experienced validation professionals to come home

Who we are:

API Consumer Brands is a leading New Zealand innovator, manufacturer and marketer of high-quality personal care and pharmaceutical products. Based in Manukau, our state-of-the-art production facilities make a wide portfolio of branded and contract manufactured products for New Zealand and around the world.

API are looking for a Senior Validation Engineer and a Validation Manager for our Manukau pharmaceuticals plant.

About the roles:

As a validation expert, you will lead, oversee and implement and perform qualification/validation protocols and studies to ensure plant validation practices and operating procedures meet API’s Policies, Health and Safety, Environmental, Production, Quality, Continuous Improvement (CI), cGMP, and Industry requirements.

The key responsibilities of the role are:

  • Driving API’s validation strategy based on strong technical and scientific rationale built on robust engineering or product specification and/or process development studies
  • Collaborate with cross-function teams (engineering, production, QA/QC and R&I) to meet project timelines within budget (cost control and management of resources)
  • Develop, implement and maintain KPI’s, and ensure proper execution of validation plans for plant & equipment, control systems, processes, and software
  • Support FAT’s, SAT’s, IQ/OQ as appropriate of plant & equipment, reviewing documentation and advising team to deliver best practice
  • Oversight of ongoing DQ, IQ, OQ, and PQ validation activities once production has commenced
  • Ensure policies and procedures are in line with GMP regulations, industry standards and meet best practices
  • Manage validation changes in line with compliance, budgets and project targets
  • Coordinate projects, liaise with external consultants and suppliers to acquire knowledge when required

What we need:

  • Bachelor or Master’s degree in a scientific field essential
  • 3 to 5+ years validation experience in a cGMP/pharmaceutical environment plus process/product engineering and QA/QC skills
  • Excellent people and stakeholder management skills
  • Advanced project and resource management skills
  • Experience with Minitab validation software would be beneficial
  • MS Office wizard
  • Experience with ICH quality guidelines

What we offer:

  • Permanent full-time position
  • Competitive rates of pay
  • Dedication to learning and development of all staff
  • Company wide recognition and wellbeing schemes
  • A team oriented, values-based workplace where hard work and diversity are championed and celebrated 

What to include in your application:

  • Cover letter explaining i) your validation experience in a cGMP environment, ii) your experience managing staff, and iii) highlighting the project you are most proud of and why.
  • Resume that matches the responsibilities and needs as stated above

If you are looking for a fresh challenge and feel that this could be the right opportunity for you, please apply now.

For more information on API Consumer Brands check us out at www.api.net.nz

*The successful candidate will be subject to a Ministry of Justice Police Check and drug testing.

Interested in this role?

Apply now