Process Controls Validation Engineer 1

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

The Process Control Validation Engineer will be the primary engineer for Cleanroom and Clean Environment Qualifications. Support equipment and analytical instrument qualifications a well as the manufacturing of pharmaceuticals in a cGMP manufacturing facility.

Specific Responsibilities include:

• Develop, review, and approve validation testing and protocols for cleanrooms and environments in conjunction with other validation team members
• Work cross-functionally with Manufacturing, Project Management, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, Information Technology (IT), and Maintenance
• Develop, review, and approve equipment/analytical instrument related Engineering Studies
• Analyze results from Engineering Studies to make conclusions and recommendations
• Design documents for facilities/equipment/analytical instruments
• Evaluated the impact of proposed changes on the validated state of facilities/equipment/analytical instruments
• Create validation schedules, coordinate execution efforts with contractors, production operators, production engineers, customers and quality assurance staff members
• Ability to work through a Management of Change system to determine the impact of proposed changes to the qualification status of equipment, software, or facilities
• Sound understanding of Quality Risk Management concepts

Who You Are:

Minimum Qualifications:

• Bachelor's Degree in Electrical Engineering, Chemical Engineering, or other Engineering discipline OR Biology, Chemistry, or other Life Science discipline
• 1+ years' quality support experience in a cGMP pharmaceutical setting (such as deviation/CAPA support, root cause and risk assessment, and/or periodic review experience)

Preferred Qualifications:

• 3+ years' quality support experience in a cGMP pharmaceutical setting
• 2+ years' of cleanroom or clean environment operation experience
• 2+ years' of validation engineering include equipment, process controls, process, cleaning, or temperature unit

• Knowledge of pharmaceutical standards, rules and guidance (e.g. FDA, EU, ISO, ISPE, etc.)

• Ability to utilize GDP during document creation and review
• Comfortable in a fast-paced environment with the ability to adjust to changing priorities. Flexible and accountable
• Awareness of EU Annex 1 Guide (Issued Year 2023)

RSREMD

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.