Validation Technician

About the role

We are seeking a candidate to assist in validation efforts at Unither Manufacturing LLC. This position will play a crucial role in executing and supporting various validation protocols, including equipment qualifications, cleaning validations, and process validations.

Responsibilities

• Executes/supports equipment qualifications, cleaning validations and recertifications, chamber recertifications, and process validations.
• Takes and delivers samples, collects and compiles data for validation reports.
• Maintains the Validation Document Library.
• Maintains test equipment and department documentation.
• Participates in audits and retrieves Validation documentation as requested.
• Ensures good documentation practices are followed during protocol executions.
• Become proficient using temperature/humidity loggers and associated DT Pro software.
• Communicates and works with outside vendors to schedule, ship, track, and receive testing equipment for calibration.
• Maintains inventory and calibration status within Blue Mountain Regulatory Asset Manager (BMRAM).

Qualifications

• HS Diploma/GED with minimum 2 years of experience in a FDA regulated environment, GMP production setting preferred.
• AAS with 1 year experience in a FDA regulated environment, GMP production setting preferred.
• BS with 0 experience.
• Above average written communication skills & writing abilities.
• Basic mechanical knowledge and aptitude.
• Ability to learn the operation and function of multiple pieces of equipment.
• Use of basic hand tools such as wrenches, screwdrivers, measuring devices.
• Knowledge of computer applications and current software is desirable.
• Knowledge of manufacturing processes and demonstrated leadership capabilities are preferred.
• General understanding of material handling machinery is advantageous.

Skills

• Demonstrated basic math skills in multiplication, division, percentage calculation, significant figures, conversion from metric to standard measures (or inverse), and weight to volume measures (or inverse).
• Familiarity using MS Word and Excel.
• An understanding of production activities and/or mechanical aptitude.
• Knowledge of production equipment operations.
• Knowledge of instrumentation, control systems, and production equipment.
• Ability to recognize situations where there is a potential impact on product quality, safety, identity and purity; seeking guidance where necessary to implement solutions to issues that are identified.

Benefits

Unither offers a comprehensive benefits package including 100% employer-paid medical premiums, 401(k) contributions, and annual performance bonuses. We are committed to providing a supportive and innovative work environment that fosters personal and professional growth.

Pay

The compensation range for this position is 20.19 - 25.00 USD.

Schedule

Details on the schedule will be provided upon interview.