Engineer - CSV

Trinity Consultants; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Trinity Consultants is seeking a QA Validation specialist to support validation activities for laboratory instruments and manufacturing equipment in the pharmaceutical industry.

The role requires strong GMP knowledge and hands‑on experience with DQ/IQ/OQ/PQ, risk assessments, specifications, deviations, and change controls. You will collaborate with QA Validation teams and help ensure data integrity and compliance across projects.

Qualifications

• Strong working knowledge of global GMPs with emphasis on validation, including computer validation.
• Excellent interpersonal, oral and written communication skills.
• Detail oriented and able to review complex documentation thoroughly.

Responsibilities

• Review and approve Qualification/Validation documentation (DQ, IQ, OQ, PQ).
• Provide QA Validation support for laboratory instruments and manufacturing equipment.
• Collaborate with QA Validation/Qualification personnel and participate in risk assessments and change controls.
• Support data integrity initiatives at the sites.

Skills

GMP knowledge

Interpersonal skills

Detail oriented

Computer validation

Education

BE or equivalent in engineering or related sciences

Tools

TrackWise

Job description

Job Description

• The scope of work for this role is to provide QA Validation support to validation activities associated with of Laboratory instruments and Manufacturing equipment in pharmaceutical industry.
• The responsibility includes review and approval of Qualification/Validation documentation DQ,IQ,OQ,PQ including Risk assessment, specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls.
• In addition, this role may provide support to the sites data integrity initiative.
• Successful candidate requires a strong working knowledge of global cGMP with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures
• Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation/Qualification personnel.
• Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation
• Should also have some experience in Mechanical Qualification

Job Requirements

Skills:

• Strong working knowledge of global GMPs with emphasis on validation, including computer validation
• Strong interpersonal, oral and written skills
• Detail oriented

Education:

• Candidate must have at a minimum a BE or equivalent, engineering or related sciences with pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation/Qualification role.
• Past experience working with Equipment Qualification, Quality Management system, Document, Document Management System, Track wise, and etc.
• Experience working with process manufacturing equipments (RMG, Sifter, Blender, compression m/c, Capsule filling m/c & etc), Utility (Water system, HVAC & etc) and other lab instruments is a plus.