Process Engineer: GMP, Equipment Qualification, & Improvement

NextPharma; Livingston; Sur place; GBP 42 000 - 65 000; Plein temps

Avantages offerts par ce poste

Free on site parking

Medical Cover

Life cover

EAP

Pension

Résumé du poste

NextPharma in the United Kingdom seeks a Process Engineer to facilitate introduction of new processes and equipment within the production department. You will lead qualification activities, train staff, and provide technical support to development and production teams to ensure timely manufacture of clinical and commercial batches.

The role requires a strong background in engineering/science within the pharmaceutical sector, experience with GMP, and excellent communication skills to collaborate

Qualifications

• Engineering and/or scientific background with 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
• Management skills are desirable merits
• 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
• Liaising with Facilities and Quality groups to maintain equipment calibration
• 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

Engineering background

Industry experience

Statistical analysis

Communication skills

Equipment qualification

Management skills

Team player

Clear written/verbal communication

Formation

Chemical/Pharmaceutical/Mechanical Engineering degree

Outils

MS Excel

MS Word

MS Project

MS Office Suite

Description du poste

NextPharma in the United Kingdom seeks a Process Engineer to facilitate introduction of new processes and equipment within the production department. You will lead qualification activities, train staff, and provide technical support to development and production teams to ensure timely manufacture of clinical and commercial batches.

The role requires a strong background in engineering/science within the pharmaceutical sector, experience with GMP, and excellent communication skills to collaborate