The role will be very varied as the company is working with new growth sectors in the biotechnology space and is also starting to carry out process validation batches for our customers products as we progress them towards commercialisation, The individual will also be involved in early equipment management, setting up user requirement specifications and carrying out factory acceptance tests/trials at machinery suppliers.
The company is in a period of fast growth so this is a fantastic opportunity for a highly motivated, energetic, self-disciplined individual to learn and quickly take on high level responsibility.
Key Tasks and Responsibilities
- Create a maintain the Site Validation Master Plan
- Create a site Validation policy and associated SOP’s
- Manage Site Validation Programme for new and existing equipment. Create a plan for regular re-validation of equipment via a risk based assessment.
- Identify costs, run rates & labour requirements related with new equipment to enable accurate costing.
- Work with Business Development to cost out work required to support customer activities.
- Develop, verify and validate new production processes
- Be part of a team that will identify new manufacturing equipment.
- Create User Requirement Specifications for the sourcing of new equipment
- Be involved in Factory Acceptance Trials of new equipment
- Support new product group in the development of packing specifications for new processes
- Write validation protocols IQ, OQ and PQ and complete the process during installation and first commercial batch manufacture.
- Identify new machinery suppliers and add them to the supplier verification system
- Train and support production personnel during Validation activities on-line.
- Occasionally support customer audits/new customer visits/ customer project meetings
- Flexible working approach as sometimes validation activities might need to be conducted out of core working hours.
- Technically astute in Pharma Validation Process covering URS/IQ/DQ/OQ and PQ activities
- Good knowledge of GMP within Pharma and Medical Devices
- Accurate completion of technical documentation
- Articulate with good numerical skills
- Well-presented and experienced in working within controlled environments (Pharmaceutical/Medical Device/Food)
The salary for this role will be £35-£45k depending on experience. We are looking at closing this at the end of May. On this occasion, LiCa Scientific Ltd is acting as an employment agency.
Please contact Matthew on 0161 443 4173 with any informal questions ahead of application or email firstname.lastname@example.org