Pharma Process Engineer: Lead New Processes & GMP

NextPharma; East Calder; Sur place; GBP 40 000 - 55 000; Plein temps

Résumé du poste

NextPharma is seeking a Process Engineer to drive the introduction of new processes and equipment in the production department in the UK. You will lead qualification activities, train staff, and ensure GMP compliance.

You'll work closely with development, production, and quality teams to deliver timely manufacture, implement process improvements, and draft SOPs for new equipment. Flexibility for extended hours and strong communication are essential.

Qualifications

• Engineering and/or scientific background with relevant pharmaceutical/chemistry/Engineering experience (or BSc equivalent education).
• Experience from similar positions in the industry.
• Strong understanding of statistical analysis.
• Flexible, structured and goal orientated team player.
• Excellent oral and written communications skills.
• Authoring and executing equipment qualification.
• Able to communicate effectively with people at all levels within the Company.

Responsabilités

• Leading introduction of new processes and equipment to facilitate clinical and commercial manufacture.
• Leading qualification of new and existing equipment.
• Training of production staff in new processes and procedures.
• Providing technical assistance to development and production staff to ensure timely completion of scheduled manufactures.
• Identifying, assessing, and implementing process improvements across functional area.
• Ensuring that clinical and commercial batches are manufactured in accordance with agreed quality standards.
• Maintaining GMP compliance in accordance with MHRA, FDA, customer, and corporate expectations.
• Drafting SOPs for new equipment to facilitate training and standardise equipment cleaning, set-up and operation.
• Leading departmental change controls, quality event investigations, and CAPA.
• Trending process KPI’s and monitoring production performance to measure effectiveness of process improvements.
• Ensure all SOPs accurately reflect best practice.

Connaissances

Statistical analysis

Communication skills

Team player

Attention to detail

Formation

Degree in Chemical Engineering, Pharmaceutical Sciences, or Mechanical Engineering

Outils

MS Office

Excel

Word

Project

Description du poste

NextPharma is seeking a Process Engineer to drive the introduction of new processes and equipment in the production department in the UK. You will lead qualification activities, train staff, and ensure GMP compliance.

You'll work closely with development, production, and quality teams to deliver timely manufacture, implement process improvements, and draft SOPs for new equipment. Flexibility for extended hours and strong communication are essential.