Validation Engineer I - FP Packaging

About the position

Responsible for validation activities where in-depth analysis, authoring protocols, teamwork and flexibility are required. Responsible to carry out validation activities such as DQ, IQ, OQ, PQ, requalification, and utilities.

Responsibilities

• Primary responsibilities include validation protocol execution (DQ, IQ, OQ, PQ), data analysis and final report preparation for utilities, equipment and instrumentation
• Serve as Operation Responsible (OR) and support Change Control activities to include: development, approval, and execution of department change control activities
• Maintain effective communication and ensure alignment in coordination with appropriate teams
• Support facility certification for new Manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the continued operation of such facilities
• Ensure systems and processes are validated as well as change control activities for systems are completed in a compliant manner in accordance with FDA, EU and NN requirements
• Actively participate on cross functional teams to determine the root cause and corrective actions for problems associated with investigations
• Complete accurate and timely assessments associated with change control activities
• Support validation of new and existing equipment, processes and instrumentation as needed
• Write and review protocols, summary reports and other documentation associated with validations
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Requirements

• Bachelor's Degree in Life Sciences, Engineering, or a relevant field of study from an accredited university required
• May consider an associate's degree in Life Sciences, Engineering, or a relevant field of study from an accredited university with a minimum of five (5) years of validation experience in a cGMP regulated industry required
• Minimum of three (3) years of validation experience in a cGMP regulated industry required
• Demonstrated understanding of the following: concepts of validation, change control processes, root cause analysis techniques, cGMP documentation practices, cGMP regulations, GMP and other industry standards pertaining to validation required
• Demonstrated understanding of technical requirements for validation and biopharmaceutical equipment, facilities and/or instrumentation required
• Excellent communication skills, both written and verbal required
• Demonstrated ability to be self-motivated, trustworthy, work in a high-paced environment, team oriented, innovative, and committed required

Benefits

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance - effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards