Mechanical Engineer

Job Title: Mechanical Engineer

FLSA Classification: Professional, Exempt

Work Location: Fall River, MA

Work Hours: General: 8:30AM - 5:00PM (may vary based on business needs)

Reports To: Site Engineering Manager

Purpose:

The purpose of the Mechanical Engineeris to assist in the mechanical/electrical maintenance, repairs, and servicing of a pharmaceutical manufacturing facility such as Utility maintenance etc.

Scope:

Mechanical Engineer conducts and directs sections of manufacturing process development projects and assists in performing more complex engineering projects to evaluate, select, and adapt standard manufacturing techniques, procedures, and criteria to increase the efficiency of plant operations.

The job duties for this position include but are not limited to the following:

• Performing daily maintenance and monitoring of equipment to ensure a high level of reliability.
• Participate in designing, implementing, and monitoring, of continuous improvement in the facility.
• Assist with installation and commissioning of new equipment.
• Evaluate and repair a wide variety of machinery and equipment using acquired knowledge, skills and experience, company supplied tools, some fabrication of parts and new and/or used but serviceable repair parts.
• Raise the change controls whenever required changes are to be made in facility and equipment.
• Prepare for operation, maintenance and engineering procedures of all equipment.
• Fill the deviation report for CAPAs and change controls as per company procedures.
• Prepare & implement procedure as per Current Good Manufacturing Practices (cGMP) guidelines by Quality Assurance (QA).
• Check and monitor for cleanliness, maintenance, upkeep of the facility, premise and equipment.
• Maintain concurrent entries of all operations/activities.
• Assist with any carpentry activities to include building walls/rooms with minimal guidance, installing repairs and finish drywall to completion, priming/painting new and existing walls, ceilings, doors, etc. throughout the site internally and externally.
• Install and troubleshoot facility electrical systems.
• Coordinate in Technology Transfer / Product Transfer with other departments.
• Coordinate with other departments for compliance statutory requirements.
• Coordinate with central utility so that required quality utilities can be provided to plant.
• Raise Capital Expenditure Requisition, work orders in SAP.
• Handle and maintain the electrical distribution system and plan for energy conservation.
• Handle the preventive maintenance of production equipment and machinery.
• Breakdown and preventive maintenance of BMS equipment and instruments.
• To check daily alarms in BMS and plan their immediate, corrective and preventive maintenance.
• Operation of BMS and service floor equipment.
• Ensure the calibration activities are completed.
• Daily monitoring and maintenance of records of the purified water generation, storage, and distribution system.

Education and Experience

• High school diploma required with minimum of three (3) years' experience in mechanical maintenance and electrical work in a pharmaceutical or industrial setting.
• Bachelor's degree, Advanced vocational training or education in pharmaceutical engineering, industrial engineering or related field of study from an accredited college/university is preferred.
• Minimum of five (5) years' experience in quality assurance in a cGMP pharmaceutical manufacturing operation environment.

Technical Knowledge and Computer Systems Skills

• Understanding of machines used in pharmaceutical manufacturing.
• Must be able to influence decision making and facilitate completion of work towards the achievement of the business plan and goals.
• Full knowledge of HVAC system with BMS controls and service to maintain them.
• DI water system maintenance and vendor coordination for the service.
• Knowledge of facility plumbing including domestic water system and sewer.
• Carpentry Skills to include Following blueprints and building plans, installing structures and fixtures, measuring, cutting, and shaping wood, plastic, and other materials, constructing building frameworks, including walls, floors, and doorframes, and repairing damaged framework or other structures/fixtures.
• Proficient understanding of HVAC systems, electrical systems and janitorial systems.
• Strong knowledge of boiler maintenance and operations.
• Strong knowledge of plumbing, building maintenance and building inspections.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Capable of conducting troubleshooting, investigations and root cause identification and analysis.
• Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
• Must be proficient in computer skills and software applications such as Microsoft Office tools.
• Experience using SAP business system and applications is a plus.
• Experience in Inhalation products (MDI) is a plus.

Professional and Behavioral Competencies

• Proficiently speak English as a first or second language.
• Must be a self-starter and demonstrate initiative to seek additional training or direction as needed.
• Must be willing and able to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday.
• Knowledge of good manufacturing practices and good documentation practices preferred.

• Ability to read, write and communicate effectively.
• Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
• Excellent organizational skills with the ability to focus on details.

Work Schedule and Other Position Information:

• Must be willing to work in a pharmaceutical manufacturing setting.
• Must be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.
• Must be willing to work some weekends based on business needs as required by management.
• Relocation negotiable.
• No remote work available.

Physical Requirements:

• This position requires the ability to do heavy lifting / bending frequently.
• Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.
• Ability to perform repairs to parts or equipment that may require cutting, brazing, TIG/MIG or stick welding.
• Requires the ability to work indoors and outdoors.
• Must be physically capable of climbing ladders, working with hardware, working in a lying position, working with arms extended overhead for extended periods of time.
• Ability to wear appropriate PPE is required.
• Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

GLOBAL COMPANY

Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.

Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)

About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.