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Process Engineer (OSD)

Process Engineer (OSD)

ShareTech GroupMeeker, CO, United States
30+ days ago
Job type
  • Full-time
Job description

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

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

and facilitate risk assessments, such as FMEA and HAZOP, to evaluate process hazards and implement mitigation

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.

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Engineer • Meeker, CO, United States