Senior Manufacturing Specialist - MTO / Process Expert

Proclinical are collaborating with a pharmaceutical organisation who are recruiting for an individual to join their team. This role is on a contract basis. The opening position currently available is for a Senior Manufacturing Specialist - MTO / Process Expert.

Responsibilities:

• Produce projects as required to form new manufacturing practices to solve daily concerns with management direction and cross-functional buy-in.
• Recognise continuous improvement prospects, share expertise cross-functionally as well as drive site and/or international application.
• You will instigate, assume accountability and handle manufacturing focused on change controls, CAPAs and planned exceptions.
• Assist with producing area assessments and conduct root cause investigations in DEV/AA/RAR reports in Trackwise.
• Write linked technical instructions and records, which involves RG/RT, processes, work instructions and forms.
• Collaborate with direct management to allocate suitable resources to tech transfers, drive continuous improvement, guarantee manufacturing instructions are concise, safe and compliant.
• Responsible for utilising knowledge to recognise, troubleshoot, and solve moderately multifaceted technical and operational issues that may arise.
• Other duties may be assigned.

Key Skills and Requirements:

• Educated to a high school degree level or similar though a university degree would be ideal.
• A mix of education and work experience may be taken into consideration.
• Demonstrable experience working within a GMP setting.
• A high attention to detail with documentation abilities.
• Mentoring capabilities for manufacturing linked actions.
• Familiarity with deputy function for MTO Manager role.
• Expertise on business and manufacturing procedures to assist on manufacturing operations.
• Know-how of manufacturing systems such as DeltaV, Syncade, SIMCA, PI, Oracle, TrackWise, etc.
• Comprehension of the basic QA and cGMP principles.
• Communication skills both verbally and in writing.
• Computer literacy.

If you are having difficulty in applying or if you have any questions, please contact Chloe Jack at c.jack@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#Engineering