Validation Specialist

Job Summary The Validation Specialist, under direct Leadership of Engineering Manager/VP, Product Innovation and Technology will be responsible for the development, execution and final reporting of Process, Equipment and Utilities URS, IQ, OQ, PQ, PV, FAT protocols and reports as required by the FDA guidelines. The candidate for this position must have excellent written and verbal communication skills, effective time-management, an innovative spirit, and the ability and desire to work both independently and collaboratively in a multidisciplinary, fast-paced, team-oriented environment.  Position Responsibilities:   Write, execute and summarize qualification protocols, reports and related documents (risk management, periodic reviews, URS, IQ, OQ, PQ, PV, FAT, etc.) to support the following: a.    Sterile Manufacturing, Filling and Packaging Equipment. b.    Facilities and Utilities - Compressed Air, Sterile Water for Injection Still and Clean rooms (ISO8, ISO7 and ISO5). c.     Process Validation d.    Cleaning Validation e.    Sterilization f.     Laboratory instruments g.    Re-qualifications of existing equipment and utilities      2.   Develop a site master plan (monthly, quarterly, bi-yearly and yearly) for calibration and validation services by coordinating scheduling and executing with external vendors for NJ 503A and NJ 503B facilities.    3.    Build a strategy and a plan to bring validation and calibration work in-house to gain revenue synergies.    4.    Provide oversight to complex qualification activities and manage multi-faceted qualification activities.    5.    Define qualification requirements based on a worst-case scenario matrix for this site.    6.    Provide strong technical expertise when reviewing and approving SOPs, protocols, change controls, deviations.    7.    Perform change control assessments and assign associated validation activities to ensure compliance with regulatory requirements.    8.    Train on Equipment Validation philosophy, approach and procedures.    9.    Coordinate successful execution of projects by working effectively with cross-functional groups.  10.    May be involved in investigation and root cause analysis for incidents reported on validated systems.  11.    Other duties, as assigned. Requirements and Qualifications:   Bachelor's degree in Engineering, or in a scientific discipline, or equivalent experience. 5+ years of experience in pharmaceutical industry preferably in Sterile Manufacturing environment. Ability to work harmoniously and effectively with others in a fast-paced environment. Ability to effectively communicate technical information in a clear, concise manner within a GMP-regulated environment. Flexibility to work off-hours and weekends as required to support manufacturing plant projects. Ability to effectively manage multiple projects simultaneously (3-6 typical). May be required to remain sedentary for periods of time. Ability and willingness to work and participate effectively in a team environment. Ability and willingness to maintain accurate and factual hard copy and electronic records. Attention to detail, safety, quality and customer requirements. Ability to effectively communicate verbally and in writing to peers and management. Ability to read information and apply what is described in the reading material to situations that may contain several details or describe processes involving several steps. Demonstrate high level of personal motivation and initiative.
Salary Range: NA
Minimum Qualification
5 - 7 years

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