- Responsible for specifying, purchasing, designing, qualifying, and handing over effective manufacturing systems ensuring plant modifications have credible delivery plans.
- Responsible for interfacing with internal / external technical experts and peers to maintain a broad knowledge of the technology and regulatory issues that impact the biopharmaceutical business enabling technology options to be identified, evaluated and compared.
- Assist in the creation / transfer of new processes and technologies to the manufacturing plant ensuring requirements for EHS and cGMP compliance.
- Manage the interface between Process Development and Manufacturing to ensure processes and transfers occur seamlessly and provide process engineering expertise to siting exercises placing new processes into the facility.
- Help in identifying improvement to an managing change of technology transfer practices to deliver continuous improvements.
- Assist in the training and coaching of project team members to ensure technical and personal objectives are achieved within agreed time frames.
- Ensure best practice operating methods are deployed and assist in resolving operational problems such as deviations, QIPs, CAPAs, etc.
- Take the lead in investigating and resolving events that arise from compliance issues.
- Develop and maintain equipment and unit operation standards and procedures utilizing 4M (Man, Materials, Machinery and Methods) approach.
- All other duties as may be assigned.
Required Skills & Abilities:
- Excellent oral and written communication skills, interpersonal and organizational skills.
- Strong leadership skills.
- Ability to train others to perform to cGMP standards.
- Proficient with Microsoft Office applications.
- Good self-discipline and attention to detail; ability to work under minimal supervision.
- Must have flexible work hours – must be willing to work outside of normally scheduled hours as necessary; including opportunities for alternative shift hours and weekends as required.
- Experience working in cleanroom environments under sterile or aseptic conditions; must have experience in engineering standards required for this type of operation.
- Must have good planning skills and must be willing to interface with and guide colleagues in many different roles and functions throughout the manufacturing facilities.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:
- Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate in a laboratory and/or manufacturing environment.
- Ability to lift up to 25 pounds; frequently, and up to 50 pounds; on occasion.
- Attendance is mandatory.
- Master’s degree preferably in Science, Engineering, or other related field and with three (3) years’ of relevant experience; OR
- Bachelor’s degree preferably in Science, Engineering, or other related field and with five (5) years’ of relevant experience
- Above experience must include one (1) year GMP experience.
- Experience developing training materials
- Experience conducting and evaluating training
- Experience with laboratory and or manufacturing instruments/equipment
- Previous leadership roles