Validation Engineer I

Perrigo•Allegan Township, MI

2d•Onsite

About The Position

Perrigo is now hiring for a Validation Engineer who will work out of our facilities in Holland, Michigan. The Validation Engineer will primarily be responsible for preparing and reviewing plans, protocols, reports, and studies associated with validation activities (Process, Packaging, Cleaning, and Equipment). The incumbent will ensure that validation events occur in conformance with approved procedures and regulatory requirements. The incumbent will coordinate the timing of validation events. This person will also assess deviations and recommend corrective actions as necessary. The Validation Engineer will perform validation periodic reviews and revise/review master plans and standard operating procedures in conformance with operational, quality, and regulatory requirements. The professional in this role will also review technical documents to ensure that validation acceptance criteria are consistent with product and process specifications.

Requirements

Bachelor's degree in Engineering, Chemistry, Pharmacy or a closely allied field, combined with one year of pharmaceutical industry experience required.
High level of analytical skills with proven problem-solving ability, and good interpersonal skills.
Experience in the interpretation and application of FDA requirements and cGMP are necessary.
Ability to write technical documents relating to applications and systems of medium complexity.
Demonstrated ability to organize multiple tasks and changing priorities to meet project deadlines.
Excellent oral and written communication skills and excellent interpersonal skills are essential.
Computer literacy is required.

Nice To Haves

Basic understanding of statistics preferred.

Responsibilities

Preparing and reviewing plans, protocols, reports, and studies associated with validation activities (Process, Packaging, Cleaning, and Equipment).
Ensuring that validation events occur in conformance with approved procedures and regulatory requirements.
Coordinating the timing of validation events.
Assessing deviations and recommending corrective actions as necessary.
Performing validation periodic reviews.
Revising/reviewing master plans and standard operating procedures in conformance with operational, quality, and regulatory requirements.
Reviewing technical documents to ensure that validation acceptance criteria are consistent with product and process specifications.