Validation Specialist

COMPANY DESCRIPTION
Nesher Pharmaceuticals (USA) LLC, a generic pharmaceutical manufacturer located in St. Louis, MO, is a subsidiary of privately held Zydus Pharmaceuticals (USA) Inc. Our business is redefining the standards for pharmaceutical performance, shaped by a passion to deliver value through innovation and an unwavering commitment to compliance. We equate business success with an environment in which employees are encouraged to maximize their potential through personal growth and accountability, resulting in outstanding results for both our people and the customers we serve. If you have the drive and desire to reach a higher level in your career as part of a growth-centric team, come join us!

SUMMARY
Prepare and execute cleaning, process and packaging validation, and equipment qualification plans and protocols. Write Final Summary Reports that summarize executed qualifications/validations. Assist in the development, coordination and execution of qualifications/validation protocols for systems governed by federal regulations as applicable in the pharmaceutical industry. Coordinate validation related activities in regards to equipment and processes being deployed in GMP environments.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Position located in St. Louis, Missouri
• Develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities/utilities supporting these operations.
• Develop and execute process validation protocols for all manufacturing and packaging processes of commercial products (and R&D products as applicable).
• Develop and execute cleaning validation/verification protocols for all commercial and R&D manufacturing, processing, and packaging equipment.
• Perform proper and timely sampling of in-process/intermediate products, finished products, rinse water and surface swabbing for testing as outlined by validation/qualification protocols.
• Perform physical testing from representative samples.
• Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.
• Gather photocopies and compile relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw material certificates of analysis.
• Investigate and resolve deviations/exceptions from the predefined acceptance criteria.
• Draw conclusions from data, observations, deviation/exception and investigation as to whether process is considered valid.
• Write summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies.
• Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.
• Ensure protocols, verifications, validation plans and summary reports generated during validation/ qualification activities are stored according to procedure.
• Maintain current knowledge in the areas of compliance and validation and other regulatory issues that may impact the Company. Work proactively to maintain the highest level of compliance in all areas. Gather current knowledge from QA/QC, regulatory, periodicals and/or appropriate training programs.
• Interact and coordinate compliance efforts with other departments including, but not limited to, Operations, Engineering, QA, laboratories (QC and R&D) and R&D to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Perform other related duties as assigned to meet departmental and Company objectives.

KNOWLEDGE/SKILLS/ABILITIES
• Knowledge of FDA regulated biotechnology or drug validation requirements including knowledge of FDA 21 CFR Parts 210 and 211.
• Knowledge of Analytical Balance, LOD Instrument, Micrometer, Friabilator, Hardness Tester, Calculator, Particle Size Analyzer, Disintegration Apparatus, Viscometer.
• Knowledge of Statistical software and calculations.
• Knowledge of manufacturing processes, sampling techniques, government regulations and guidelines pertaining to those areas.
• Knowledge of SCADA control system.
• Strong understanding of cGMPs and validation/qualification concepts.
• Ability to read, program, troubleshoot PLC Ladder Logic and HMI software.
• Ability to analyze pharmaceutical processes to determine critical parameters and critical quality attributes and design testing in the form of protocols to ensure robust and repeatable process. Must have in-depth knowledge of equipment set-up and operation, facility qualifications, master validation policies and protocol generation, and protocol execution.
• Ability to perform qualification and validation reporting.
• PC proficiency using Microsoft Office suite.
• Excellent written and verbal communication skills.
• Highly organized and detailed.
• Ability to read and comprehend written technical procedures, as-built drawings, P&IDs, blueprints as well as cGMP and SOPs.
• Ability to accurately perform mathematical calculations required by work assignments.

EDUCATION/EXPERIENCE
• Bachelor's degree in Chemistry, Pharmacy, Engineering or related Science; or equivalent combination of Bachelor's degree and pertinent, progressive experience in pharmaceutical or other highly regulated industry.
• Three years' proven experience in validation, with particular knowledge of 21 CFR Part 210 and 211.
• Experience in 21 CFR Part 11 desired.

WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:
1. Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.
2. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
3. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:
1. Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.
2. Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.
3. Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.
4. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

We are an equal opportunity employer M/F/D/V.

Current Openings for Validation Specialist Jobs at Nesher Pharmaceuticals (USA) LLC