To lead and manage all maintenance activities in the Parenteral production areas. These activities include but are not limited to the execution and continuous revision of the reliability centered maintenance program (Job Plans Structure Based in Preventive, Predictive, Proactive and Corrective maintenance), perform work orders and provide daily support to the manufacturing schedules of Parenteral areas (PSA, ParLyo and PVA).
This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
Major Responsibilities :
to-day equipment and systems support) for the site by coordinating maintenance services with other operations leaders and planning personnel.
and ensures they are skillfully performing assigned work orders and troubleshooting and properly documenting it.
g. FMEA / FMECA documents, RCA (root cause analysis), etc.)
Knowledge / Skill :
1. Bachelor in Science Degree in Engineering, Electronics or related field
2. Five (5) years experience in the operation / maintenance of pharmaceutical manufacturing equipment (e.g. Blenders, Milling Machines, Tablet Press Machine, Aseptic Processing Equipment, Isolators and Lyophilization Process Equipment).
3. Broad knowledge of relevant governmental regulations, cGMPs and guidelines pertaining to a biopharmaceutical manufacturing plant.
4. Ability to provide support during external and internal regulatory audits (FDA, EMEA, Otsuka, Sanofi, etc.)
5. Ability to troubleshoot problems for highly technical equipment.
6. Ability to read and interpret complex mechanical, pneumatic and electrical blueprints. In addition, general knowledge in automated equipment functionality and architecture.
7. Bilingual English / Spanish, both written and verbal and ability to read technical English and equipment manuals
8. Ability to understand and use basic computer software packages like Excel, Word, Power Point, Internet, etc. Computer literate
9. Excellent interpersonal skills and teamwork oriented, able to work under pressure with subordinates, peers, management and clients.
10. Self-starter and initiative to undertake / execute activities with minimum supervision.
11. Ability to review SOPs and work instructions
12. Flexible and responsible
13. Significant ability and aptitude to analyze data detecting inconsistencies, determining relative importance and to solve complex technical situations based on data
14. Self-starter and well organized and have the capacity to interact effectively with people
15. Ability to keep work pace and / or meet deadlines
16. Ability to exercise good judgment
17. Willing to work irregular hours, rotative shifts, weekends and holidays