Manager, Engineering (Sterile Project)

Job Description

Title: Manager, Engineering (Sterile Project)

Company Name: One Pharma Limited

Vacancy: 1

Age: 35 to 42 years

Job Location: Bogura

Salary: Negotiable

Experience:

• 10 to 12 years

• Bachelor’s degree in Mechanical or Electrical Engineering from a reputed institution.

• 10 to 12 years

• Age 35 to 42 years
• Only Male

• Industry Experience: Minimum 10–12 years of experience in a pharmaceutical manufacturing plant, with at least 5 years in a supervisory role (Assistant Manager/ Deputy Manager).

• Technical Expertise: Mandatory experience minimum 10 years in Sterile/Injectable facilities, including hands-on knowledge of cleanroom standards and aseptic utilities.

• Audit Exposure: Proven experience in handling regulatory inspections (e.g., DGDA, WHO, PICS, or USFDA).

• Leadership Skills: Strong problem-solving abilities and the capacity to lead a multidisciplinary team under tight deadlines.

• Quick and effective decision-making capability·     

• Proactive, smart, and positive attitude with strong problem-solving ability·

Context:

One Pharma Ltd. embarked on its pioneering journey in November 2015 with a focus on incorporating cutting-edge manufacturing technology and producing globally acclaimed pharmaceutical products for the patients of Bangladesh and beyond. One Pharma Limited is looking for an experienced, reliable, honest & dedicated candidate for the position of Manager, Engineering (Sterile Project) for its factory (BSCIC, Bogura).

Job Responsibilities:

1. Maintenance & Operational Leadership

• Operational Oversight: Supervise daily engineering and maintenance activities for both sterile and general manufacturing units to ensure zero production downtime.

• Preventive Maintenance (PM): Develop and implement robust PM schedules for production machinery and utility systems to maximize equipment lifecycle and reliability.

• Troubleshooting: Lead the technical team in identifying and resolving complex mechanical or electrical failures promptly.

2. Project Execution & Validation

• Lifecycle Documentation: Assist in the preparation of User Requirement Specifications (URS) and perform detailed Design Reviews.

• Qualification/Validation: Coordinate and execute validation protocols, including DQ, IQ, OQ, and PQ, for new sterile equipment and facilities.

• Commissioning: Actively participate in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) for new projects.

3. Critical Utility Management

• Clean Utilities: Oversee the operation of critical sterile utilities, including HVAC, Purified Water (PW), Water for Injection (WFI), Pure Steam, and Compressed Air.

• Plant Utilities: Manage the maintenance of the Boiler, Chiller, Generator, Substation, and ETP/WTP systems.

• Environmental Control: Monitor Cleanroom environments and Building Management Systems (BMS) to ensure compliance with sterile manufacturing parameters.

4. Sterile Area Support

• Provide high-level engineering support for specialized systems such as Aseptic Filling lines, Autoclaves (Sterilization), and Lyophilization (Freeze-drying) units.

5. Compliance & Documentation

• cGMP Adherence: Ensure all engineering activities strictly follow current Good Manufacturing Practices and Safety protocols.

• Documentation Management: Maintain and review accurate logbooks, Standard Operating Procedures (SOPs), and equipment maintenance records for audit readiness.

6. Team & Vendor Management

• Supervision: Direct and mentor junior engineers, technicians, and external contractors during project phases or routine maintenance.

• Resource Optimization: Monitor energy consumption and implement cost-saving initiatives and continuous improvement projects.

• Provident fund,Mobile bill
• Salary Review: Yearly
• Festival Bonus: 2

• Competitive Career Growth

• Other Financial/Non-financial Benefits