Site Engineering Head - USFDA OSD Facility

Michael Page; India; On-site; INR 2,000,000 - 3,000,000; Full time

Benefits offered by this job

High visibility with leadership

Influence on engineering strategy

Opportunity to lead large-scale teams

Job summary

A reputed pharmaceutical manufacturer seeks an experienced engineering leader to head operations at a USFDA formulation site in India. This role requires managing engineering functions, including utilities and compliance mechanisms, and leading a team of over 70 engineers. Candidates should possess a degree in Mechanical or Electrical engineering and have direct experience with USFDA audits. The position offers high visibility and influence over long-term engineering strategy in a regulated environment.

Qualifications

• Minimum 2+ years as HOD Engineering or equivalent.
• Hands-on experience with USFDA audits in the last 3 years.
• Stability with a minimum of 3+ years tenure in current and past roles.

Responsibilities

• Lead engineering for a highly regulated USFDA formulation site.
• Own engineering operations across process equipment and utilities.
• Act as engineering leader for USFDA, MHRA, and EU audits.

Skills

Leadership

Compliance with USFDA audits

Engineering operations

Process equipment management

Automation and digitization

Education

B.E./B.Tech or M.E./M.Tech (Mechanical or Electrical)

Job description

About Our Client

Our client is a reputed pharmaceutical manufacturer operating USFDA‑approved formulation facilities, with a strong compliance track record across global regulatory bodies. The organization runs large, complex manufacturing operations and places high emphasis on engineering robustness, audit readiness, and operational discipline.

Job Description

• Lead engineering for a large, highly regulated USFDA formulation site
• Enterprise‑scale role with authority over utilities, assets, and audits
• Head the entire site engineering function, leading a team of 70+ engineers and technical staff.
• Own engineering operations across process equipment, utilities, maintenance, and site infrastructure.
• Act as the single‑point engineering leader for USFDA, MHRA, and EU audits, ensuring continuous compliance.
• Drive engineering readiness, reliability, and lifecycle management for OSD and sterile manufacturing blocks.
• Partner closely with Plant Head and Corporate Engineering on capex planning, upgrades, and technology deployment.
• Ensure regulatory compliance, documentation robustness, and audit preparedness at all times.
• Strengthen automation, digitization, and system‑driven maintenance practices across the site.
• Build a strong succession pipeline and a high‑performance engineering culture.

The Successful Applicant

• B.E./B.Tech or M.E./M.Tech (Mechanical or Electrical).
• Currently an HOD Engineering / Site Engineering Head (minimum 2+ years in HOD role or equivalent large block ownership).
• Direct reporting exposure to Plant Head / Corporate Engineering Head / Head Engineering.
• Hands‑on experience facing USFDA audits within the last 3 years.
• Prior exposure to multiple USFDA and MHRA/EU audits across previous organizations.
• Strong experience with process equipment and utilities in oral solid dosage manufacturing (injectables exposure is desirable; strong OSD background is acceptable).
• Demonstrated stability with a minimum of 3+ years tenure in current and past roles.
• Exposure to process automation, MES, or digitized manufacturing systems will be a strong advantage.
• Background from reputed USFDA‑approved formulation manufacturing plants only.

What's on Offer

• A site‑critical engineering leadership role in a globally regulated manufacturing environment.
• High visibility with both corporate and plant leadership, influencing long‑term engineering strategy.
• Opportunity to lead large‑scale teams, assets, and compliance programs.
• A role suited for seasoned engineering leaders seeking scale, authority, and impact rather than incremental responsibility.