Lead Technician

Job Title: Lead Technician

Reporting to: Senior Facilities Manager

Department: Engineering & Facilities

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.

Job Summary

The Lead Technician is a skilled position responsible for both predictive and preventive maintenance of all equipment on a diverse range of systems.  This includes facilities, core utilities, and GMP clean utilities common in the pharmaceutical/biopharmaceutical industry.  This includes not only the physical and skilled aspects to the job, but also planning and communicating work, working with software systems to document work performed according to Good Documentation Practice (GDP). 

Primary Responsibilities:

• The individual will perform various duties as required to support 24/7 Plant and Process operations in a cGMP environment
• Must be able to work flexible shifts including weekends
• Must be able to respond to emergency on call
• Monitor critical plant systems
• Perform system testing and meter readings
• Perform planned and unplanned maintenance
• Work with and manage vendors
• Troubleshoots mechanical and electrical issues that might arise
• Maintain records of building operations, repairs, parts, and equipment
• Creation and execution of Preventative Maintenance documents and Standard Operating Procedures
• Will write Deviations, CAPSs, Change Controls and SOP Revisions
• Will assist in failure investigations (root cause) and help provide corrective/preventive actions to Deviations and equipment failures
• Must comply with all applicable rules and regulations of Syngene and the pharmaceutical/biotechnology industry. This includes FDA regulations such as cGMP, GDP, EH&S regulations, and company regulations such as the employee handbook.

Education & Qualifications:

• HS Diploma/GED
• Maryland Third Grade Stationary Engineering License with Second Grade preferred
• Prior clean room experience
• Universal CFC Refrigerant License preferred
• Prior experience in general utility systems, boilers, electrical, HVAC, and refrigeration systems
• Prior experience with critical utility systems, purified water systems, clean steam, pharmaceutical gasses, classified HVAC systems
• Must have the ability to multi-task and coordinate workload by priority
• Must be customer service and quality driven
• Prior cGMP experience
• Prior experience in an environment that implemented and maintained advanced maintenance techniques such as preventive and predictive maintenance programs (PMMS, TPM, Predictive Maintenance)

Additional requirements for this role:

Candidate should have hands-on experience of Typing/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, lift/carry 50 lbs, and pull 50 lbs.  Use a phone, fax, copier, and computer. Use hand tools and operate the forklift. Organize/coordinate, analyze/interpret, calibrate precise measurements, solve problems, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents.  Drive automatic/standard vehicle. Work outdoors, around noise above conversation level, in hot/cold temperatures, in high humidity, where ventilation is needed, in multiple locations, with restricted access to laboratories, in contact with Select Agents, and with exposure to animals, animal areas, or equipment used in animal areas.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.