- Requires excellent technical knowledge with good operational and/or project engineering experience i.e. all phases of the GAMP life cycle, validation phases, final hand-over and training.
- In-depth knowledge of control system validation FAT to PQ (protocol generation, review, execution and reporting).
- In-depth knowledge of GAMP 4/cGMP requirements.
- Siemens S7 PLC (or similar control systems) and SCADA experience.
- Strong analytical skills and documentation skills.
- Strong understanding of relevant pharmaceutical industry regulatory requirements.
- Strong communication and interpersonal skills. Highly motivated with ability to work effectively with multidisciplinary teams or independently
- Strong team player.
- Good proactive approach & manner
- Bachelor’s Degree in Engineering (Electrical, Electronic, Mechanical or Chemical)
- Additional qualification and/or Master’s degree an advantage.
- +12 years’ experience, with at least 8 years prior experience as an Automation Engineer in a pharmaceutical manufacturing environment.
- New facility start-up (plant commissioning and validation) experience desired.
- Experience with PLCs and SCADA systems
- Experience of data historian and MES systems
- URS generation, FDS review, FAT/SAT protocol generation/review and Software FAT & SAT execution.
- Experience of UMS, BMS and EMS systems – their specification, testing, commissioning and validation.
- Experience of engineering consultant and solution provider co-ordination.
- Experience of sterile vial fill and packaging line operations an advantage but not essential.
Work Environment/Hazards and Physical Demands:
The physical demands include those required of a normal office position and engineering shop floor support in a cleanroom environment. While performing the duties of this job, the employee is regularly required to use hands to manipulate objects or controls and to sit, talk, see, and hear. The employee is frequently required to reach with hands and arms, stand, walk, and lift or move up to 5kg. The employee is occasionally required to crouch. The employee is occasionally required to climb ladders to access technical areas. The employee must be capable of wearing sterile cleanroom garb in a grade B environment. The employee must be capable of wearing protective and/or safety equipment as needed.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The role will typically require infrequent, off site national and international travel, for business or equipment/project review meetings, including overnight stays, up to 10% of the time. However during the initial start-up phase of the manufacturing facility project, this may be as high as 30-50% for the first 12 months.