Head Engineering Department in Pharma

Novugen Pharma Uzbekistan is looking for Head Engineering Department for its plant in Syrdarya region:

Strategic Result Areas (SRAs) of the Position
&

Key Result Areas (KRAs) & Job Description of the Position

I. Strategic Engineering & Expansion Functions

1. Must be able to develop the As-Built drawing of plant utilities like HVAC schematics, zoning drawings, P&ID of water treatment system & process equipment etc.
2. Must be able to write/review URS of Utilities and production equipment as per GEP & GMP requirements.
3. Must be able to perform the FAT/SAT of production equipment & utilities with proper documentation like DQ, FS, IQ, OQ, PQ etc.
4. Provide strategic direction for plant expansion / up-gradation / modification of machines, equipment and services to improve overall productivity and efficiency.
5. Prepare, execute CAPEX and manage all project related to facility expansion, induction of new equipment, capacity enhancement etc.

II. Regulatory Compliance Functions

1. Responsible for managing all HVAC validation functions including Testing, adjustment and balancing work (TAB). It includes the air and water balancing of HVAC system.
2. Modify the existing facility and utilities as per latest international cGMP guidelines like WHO, PICs, EU, etc. wherever required. Ensure that the facility is always ready for any local or international Audits, as per the regulations.
3. Ensure that all Engineering activities are performed meeting the cGMP requirements.
4. Make sure that all SOPs and related O&M log books are available at all time and updated periodically and ensure that the calibration activity at plant is updated.

III. Operations & Management Functions

1. Ensures that all production machines, utilities and ancillary equipment etc. are kept in efficient working condition. Plan, execute and monitor the preventive maintenance plan for production, Utilities and ancillary equipment of entire plant and keep its record.
2. Manage the spare parts of machines and maintain adequate inventory to timely perform the corrective maintenance.
3. Must be able to manage installation and commissioning activities of new machines, optimize and reorganize layout for more efficient operations.
4. Ensure safe systems of works exist to cover all potentially hazardous operations.
5. Ensure the efficient utilization of plant to reduce the energy cost.

Ensure to reduce downtime of production machine & optimize OEE of the production equipment.

Position Profile

1. A mature professional, who has worked in progressively responsible positions as a maintenance officer, maintenance manager, utilities manager particularly on HVAC and Purified Water System, of a pharma plant with international accreditations (WHO, PIC/s EuroAsia – Russia, Kazakhstan or Belarus)
2. Currently needs to be at a senior manager level for at least 4 years with a reputable GMP compliant company.
3. Must have faced as a lead engineer or a second line engineer for at least 4 to 5 audits of regulatory agency of a EuroAsian category or equivalent regulatory agency.
4. Must have hands on experience in managing a pharma engineering department in a pharma plant, generic or MNC pharmaceutical company/companies whose business is of exports to a market like EuroAsia, or equivalent.
5. Must have between 8 to 10 years of experience with a growth oriented and successful pharmaceutical company which has expanded its plant over the years.
6. Must be able to or is keen to work in a cross functional team in a global organization across a matrix environment.
7. Must be very hard working. Must be willing to travel to carry out FAT and SAT etc., when required.
8. Should be in the age bracket of about 33 years to 44 years. In exceptional cases, someone in the bracket of 45 to 52 years is acceptable.
9. Provide Leadership and coaching to the engineering and projects teams, mechanics, technicians and the production team.

Education & Languages

1. Must have a graduate degree in an engineering discipline from a reputable and recognized university.

Must be proficient in English. Knowledge of Russian will be an added advantage.