Technical Operations Officer

Technical Operations Officer

The Technical Operations Officer is responsible for the review of executed PI sheets and batch records, complete Manufacturing investigations and close out of CAPAs following completion of manufacture campaigns. The aim of this role is to provide effective support to Manufacturing operations to assure client expectations and project timelines are fulfilled.

Key Stakeholders: Internal

- Head of Technical Operations - Manufacturing - Process Development personnel - Other support functions (QC, QA, Engineering)

Key Stakeholders: External

- Site customers and regulatory bodies

Reporting Structure

- Directly reports to Technical Operations Manager

Key Roles/Responsibilities

- Review of executed PI Sheets for completion accuracy; - Work with QA to review and close out any clarifications or queries raised by the client or internally; - Work with the Senior Technical Operations Officers to complete actions raised as a result of change control; - Work with the document control team to ensure that PI sheets are requested in a timely manner, prior to Manufacturing start date; - Work with the Shift team leaders to ensure labels required for manufacture are requested/printed as required; - Review and update cleaning and buffer PI sheets; - Aid investigations resulting from process related deviations; - Collation of data required for end of campaign reports; - Review and update SOPs, OIs and PI sheets; - Support Senior Technical Operations Officer on project specific tasks as required. - Providing hands on support for FAT/SAT, ensure training and documentation to optimize utilization and enhance operational capabilities is created and available for operations.

Essential Qualifications

- Degree in a scientific subject or the equivalent GMP experience.

Essential Experience

- Good chemical/bio-processing industry knowledge - Good working knowledge of GMP - Solid understanding of chemical unit operations and process chemical reaction hazards. - Experience of updating and creating batch record documentation. - Experience of implementing change using change control principals. - Excellent verbal and written communication skills - Experience of working in clean rooms (desirable)

Competencies

Teamwork - As a team member, the ability and desire to work cooperatively with others on a team

Communication - The ability to ensure that information is passed on to others who should be kept informed.

Building Collaborative Relationships - The ability to strengthen partnerships with others inside the organization who can provide information, assistance, and support.

Attention to Detail - Ensuring that one's own and others' work and information are complete and accurate.

Interpersonal Awareness - The ability to notice, interpret, and anticipate others' concerns and feelings, and to communicate this awareness empathetically to others.

Customer Awareness - The ability to demonstrate concern for satisfying one's external and/or internal customers.