Manager - Engineering & Maintenance Job at Biocon, Cranbury, NJ

SGJyTGJQeEVIR1RMTHZVdjc5dERCOEFudHc9PQ==
  • Biocon
  • Cranbury, NJ

Job Description

1. Equipment & Facility Maintenance

  • Lead maintenance of OSD manufacturing equipment such as blenders, granulators, fluid bed dryers, sifters, mills, tablet presses, capsule fillers, coating pans, dust collectors, compressors, chillers, boilers, AHUs, and dehumidifiers.
  • Implement robust Preventive Maintenance (PM) and predictive maintenance programs.
  • Conduct breakdown investigations and implement corrective actions.
  • Ensure critical facility systems (HVAC, electrical, plumbing, fire systems, BMS/EMS) are maintained and operate to required standards.

2. Regulatory Compliance & Documentation

  • Ensure compliance with FDA, cGMP, 21 CFR Part 11, OSHA, and related regulatory requirements.
  • Maintain records including PM logs, calibration reports, service documentation, change controls, deviations, and CAPAs.
  • Support internal and external audits (FDA, DEA, ISO, and customer audits).

3. Utilities & HVAC Systems Management

  • Manage key utilities such as compressed air, nitrogen, vacuum, HVAC, chilled water, steam, and RO/DI water systems.
  • Ensure qualified and compliant environmental controls for classified OSD manufacturing areas.
  • Maintain pressure cascades, temperature and humidity controls, and HEPA-filtered air systems.

4. Equipment Qualification & Validation

  • Work with Validation and QA teams on IQ/OQ/PQ protocols.
  • Manage requalification schedules and ensure equipment remains in a validated state.
  • Provide engineering assessments for change controls.

5. Safety, Risk Management & Compliance

  • Ensure adherence to OSHA, NFPA, and site safety requirements.
  • Implement safety programs including LOTO, confined space, hot work, and electrical safety.
  • Conduct incident investigations and lead corrective actions.

6. Spare Parts & Vendor Management

  • Maintain optimum inventory of critical spare parts.
  • Manage vendors, annual maintenance contracts (AMCs), and service agreements to control maintenance costs.
  • Evaluate and onboard modern technologies and suppliers.

Qualifications & Experience

Education:

  • Bachelor’s degree in mechanical, Electrical, Chemical, or Industrial Engineering (or equivalent).
  • Preferred: Master’s degree or certifications such as CMRP or PMP.

Experience:

  • 8–15 years of engineering and maintenance experience in OSD pharmaceutical manufacturing.
  • Strong knowledge of manufacturing and packaging equipment, utilities, HVAC, and cleanroom systems.
  • Experience with FDA/DEA audits and equipment validation.

Must have a valid work permit.

Job Tags

Similar Jobs

Greeley County Health Services

Family Physician Job at Greeley County Health Services

H&H Leadership Solutions invites you to explore an outstanding Physician opportunity with Greeley County Health Services . At GCHS, we believe healthcare should be personal, community-rooted, and backed by a team that truly cares. Were seeking a Family Medicine ...

Confidential

Human Resources Director Job at Confidential

 ...design and execute strategies that enhance organizational performance, align talent with...  ...Business Administration, or Organizational Psychology) preferred. ~12+ years of...  ...leadership role within manufacturing or industrial sectors. ~ Proven success supporting... 

I Saw The Sign

Sign Installation Specialist (Commercial) Job at I Saw The Sign

 ...At I Saw The Sign, we're more than just a sign company. We're storytellers. Our dynamic signage solutions, from eye-catching storefront...  ...We are seeking a dedicated and skilled Outdoor Commercial Sign Installation Specialist to join our team. This full-time, on-site position... 

Neptune Construction Group LLC

Social Media Content Creator Job at Neptune Construction Group LLC

 ...Job Description Part-Time Social Media Content Creator Position Overview Neptune is looking for a part-time Social Media Content Creator to help build our online presence and support basic marketing tasks. This role focuses on creating simple content, posting... 

Health and MedSpa

Family Nurse Practitioner Job at Health and MedSpa

 ...We are seeking an experienced and highly motivated Family Nurse Practitioner Medspa to join our growing team. The ideal candidate will have...  ...Qualifications: Current and valid Florida Family Nurse Practitioner (NP) or Physician Assistant (PA) license. Minimum of 1-2 year...