Validations Engineer I or II

Education: BS with 2-5 years of relevant experience or MS or PhD in Chemical or Mechanical Engineering or a related discipline.

Experience: Must have 2+ years Pharmaceutical Process Development and Validations experience, 5+ years is preferred.

Specialized knowledge or training: Experience with Process Validations, Cleaning Validations, Scale-up, and equipment qualifications. Experience with performing IQ, OQ and PQ functions for equipment used on different products (tablets, solutions, or topicals), Statistical process performance and Project Management are a plus.

Other Skills: Strong Technical writing and documentation skills are necessary (cGMP, protocols, reports, OOS investigations, and laboratory notebook documentation).

Travel required in this position

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Employee Ownership (ESOP):

Company-funded retirement contribution of approximately 18% of pay, plus 401(k)

Competitive base salary with performance-based bonus opportunity

Comprehensive benefits package: Medical, Dental, Vision, Life, Disability, FSA, and Pet Insurance

Generous paid time off, paid holidays, and parental leave

Fitness and tuition reimbursement programs

The

Validation Engineer

is responsible for process and product validation from equipment design to FDA approval and continued process verification. This position manages projects with Operations for the commissioning and qualification of equipment to maximize efficiency, safety, continuous improvement and apply lean manufacturing principles and techniques.

Oversee manufacturing equipment and facility commissioning projects including design, selection, and qualification. Develop protocols and write reports; to appropriately design the protocols, must be able to understand the purpose and objective of the study. Able to write and execute IQ, OQ and PQ protocols against project timelines. Has effective organization and time management skills. Multi-tasks well, delegates appropriately and considers others when planning. Develops effective plans, anticipates problems and looks for contingencies.

Supports project technical development (Manufacturing Controls), from formulations to approval and launch as it applies to project design. Works with Formulators during laboratory batches to understand the process. Is able to navigate complex projects and view problems as opportunities. Shows confidence in ambiguous and stressful situations. Solicits and welcomes feedback from others.