Validation Engineer

Job description

Payrate:

$40.00 - $44.00/hr.

Summary:

The ideal candidate will have 5 years of experience with a B.S. in Science, Engineering, or Pharmacy. The role requires flexibility in working hours to support manufacturing needs.

Responsibilities:

Coordinate cleaning validation activities and prepare and execute protocols and reports for cleaning development and validation. Perform investigations of deviations and discrepancies. Support authoring and executing

CV/CHT/SHT

protocols, progress package work, and wrap up executed studies. Lead and perform on-floor CV execution and sampling, providing technical support and sample management for cleaning activities associated with the manufacturing process. Design and develop cleaning procedures for new products and manufacturing equipment. Investigate and conduct troubleshooting/root cause analysis of cleaning-related incidents, deviations, and cleaning out of specification results for non-validated or under-development cleaning procedures. Support the periodic review of cleaning validation studies. Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan. Train manufacturing and QC/QA personnel on cleaning validation documentation.

Qualifications:

Proficient with KNEAT or similar programs. Strong understanding of GMPs and global regulatory expectations. Ability to interpret equipment design, P&IDs, and process flow diagrams. Excellent technical writing and documentation skills. Strong analytical and problem-solving abilities. Effective communication and cross-functional collaboration. Ability to work independently and manage multiple priorities.

Desired Skills:

Project management experience is a plus.

Pay Transparency:

The typical base pay for this role across the U.S.

is:

$40.00 - $44.00 /hour . Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. Consent to

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