Process Engineer (OSD)

We are seeking a highly skilled and motivated Process Engineer with extensive experience in Oral Solid Dosage (OSD) manufacturing to join our team. The ideal candidate will be responsible for leading cross-functional teams and challenging design assumptions to ensure robust, compliant, and cost-effective pharmaceutical facility designs and operations. This role plays a key part in the development, optimization, and execution of process solutions within a regulated environment.

Key Responsibilities:

• Lead the design, development, and optimization of OSD manufacturing processes including blending, granulation, drying, compression, coating, and encapsulation.

• Collaborate with multidisciplinary teams (engineering, validation, QA, manufacturing, etc.) to drive project execution from concept through commissioning.

• Support equipment selection, procurement, FAT/SAT, installation, and qualification of OSD manufacturing systems.

• Ensure compliance with cGMP, FDA, EMA, and other regulatory agency guidelines during design, startup, and routine operations.

• Lead and facilitate risk assessments, such as FMEA and HAZOP, to evaluate process hazards and implement mitigation strategies.

• Develop process documentation including P&IDs, process flow diagrams (PFDs), URS, SOPs, and validation protocols.

• Provide technical leadership and mentorship to junior engineers and project team members.

Qualifications:

• Bachelor’s or Master’s degree in Chemical Engineering, Mechanical Engineering, or a related field.

• Minimum 5 years of experience in pharmaceutical OSD manufacturing processes.

• Proven experience leading engineering teams and challenging facility or process design assumptions in a constructive, solution-oriented manner.

• Strong knowledge of pharmaceutical regulations (cGMP, FDA guidelines) and validation lifecycle (IQ/OQ/PQ).

• Excellent project management, leadership, and communication skills.

• Ability to work effectively in a dynamic, fast-paced, and cross-functional environment.
  
  
  Note: The candidate should be able to commute to the site since we do not provide  relocation package.

"Drug Free Workplace Policy: In accordance with our commitment to maintaining a safe and productive work environment, all applicants for employment with our company are required to affirm their commitment to a drug-free workplace and consent to pre-employment drug testing as a condition of employment."

Share Tech Group is committed to being an equal opportunity employer, fostering a diverse and inclusive workplace where all individuals are treated with respect and provided with equal opportunities for employment and advancement.