Position Title: Maintenance Manager – Process Engineering
Department: Engineering & Maintenance – Technical Operations
Preferred Nationalities: Iraqi or Indian
Company: Alalmyah Pharma Ind.
Location: Iraq - Baghdad - Altaji
Qualification & Functional Knowledge Requirements
Bachelor’s degree in Mechanical Engineering or a related field.
Minimum 15+ years of experience in mechanical engineering within the pharmaceutical industry, specifically covering OSD, OLD, ampoules, and LVP manufacturing.
Strong understanding of production and packaging equipment and processes for each dosage form.
Familiarity with FDA regulations, cGMP requirements, and equipment validation processes.
Proficiency in CAD software (AutoCAD, SolidWorks) and engineering analysis tools.
Excellent problem-solving skills and strong attention to detail.
Strong verbal and written communication skills, with the ability to collaborate effectively across departments and prepare detailed technical reports and presentations.
Ability to work collaboratively in a team-oriented environment.
Key Skills & Technical Expertise Required
Oral Solid Dosage (OSD) Manufacturing
Installation and qualification of granulation systems (high-shear, fluid bed).
Milling process implementation using cone mills or hammer mills.
Blending operations oversight ensuring formulation homogeneity.
Compression system maintenance and optimization (tablet presses, punches, dies).
Coating operations using pan coaters or fluidized bed coaters.
Installation and qualification of tablet/capsule packaging lines (bottling, blistering, cartoning).
Collaboration with packaging and production teams to define material and equipment specifications.
Implementation of automated packaging lines to enhance efficiency and reduce downtime.
Oral Liquid Dosage (OLD) Manufacturing
Installation and qualification of liquid mixing systems ensuring proper homogenization.
Implementation of volumetric and gravimetric liquid filling lines.
Design and oversight of packaging lines for vials, bottles, and pouches.
Installation and qualification of filling and labeling systems ensuring accuracy and compliance.
Operation of labeling systems to maintain traceability and meet regulatory standards.
Ampoule Production
Installation and qualification of ampoule filling machines ensuring precise volume control.
Implementation of sealing systems (e.g., flame sealing) ensuring ampoule integrity.
Oversight of automated inspection systems for quality assurance.
Installation and qualification of packaging equipment for ampoules covering filling, sealing, and inspection.
Assurance of sterility, quality, and contamination control.
Large Volume Parenteral (LVP) Manufacturing
Installation/qualification of bulk preparation systems ensuring sterility and raw material quality.
Implementation of aseptic filling lines for large-volume products.
Oversight of sterilization processes (autoclaving, filtration).
Installation/qualification of LVP packaging solutions including flexible bags and bottles.
Risk assessment and performance evaluation of LVP filling and packaging operations.
Implementation of sealing and labeling systems ensuring full regulatory compliance.
Process Equipment Validation
Execution of full equipment validation lifecycle: IQ, OQ, PQ.
Collaboration with QA, production, and engineering teams to ensure compliance with FDA and cGMP guidelines.
Preparation and maintenance of validation protocols, reports, and SOPs.
Continuous Improvement
Identify and implement process improvement opportunities based on validation insights and equipment performance.
Stay updated with industry trends, technological advancements, and best practices in pharmaceutical engineering and validation.
