6460 - Senior CQV Engineer / Senior Validation Engineer

Responsibilities

Designing validation plans; Conducting and documenting impact and risk assessments with a full understanding of equipment/system/software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes; Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits; Designing and executing engineering studies for critical process parameter definition and verification prior to validation; Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader; Running test scripts and documenting results; Adherence with project schedule for all assigned activities; Maintaining clear, detailed records qualification and validation; Documenting impact and risk assessments as part of a team; Completing user interface testing, software verification, and complete alarm testing on automated systems; Developing, reviewing, and executing testing documentation; Making recommendations for design or process modification based on test results when executing test scripts; General understanding of capital equipment implementation and process knowledge; Understanding validation documents, URS, IQ, OQ, PQ

Requirements

Must be able/willing to work onsite in the Raleigh/Durham metropolitan area; Must be willing to meet potential future travel requirements (10-50%); Bachelor’s Degree or equivalent required; Ability to mentor and guide less experienced team members; Ability to communicate effectively with clients; Proven ability to identify areas of business expansion and report to management team for follow-up; Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate; Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization; 4 - 6 years of demonstrated role relevant experience; Demonstrated experience in leading CQV activities specific to pharmaceutical manufacturing requirements; Proficiency using PC and Microsoft Office tools; Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms; Ability to work as part of a team; Strong problem-solving and critical thinking skills; Excellent organizational and time management skills; Strong attention to detail; GMP and Good Documentation Practice; Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes); Basic skills with EXCEL and PowerPoint; Strong interpersonal skills and clear communication capabilities; Experience with and tolerance for high levels of challenge and change; Experience in GMP regulated environment; Proven attention to detail and organization in project work; Capable of working on assigned tasks without mentorship

Benefits

High growth potential and fast-paced organization with a people-focused culture; Competitive pay plus performance-based incentive programs; Company-paid Life, Short-Term, and Long-Term Disability Insurance.; Medical, Dental & Vision insurances; FSA, DCARE, Commuter Benefits; Supplemental Life, Hospital, Critical Illness and Legal Insurance; Health Savings Account; 401(k) Retirement Plan (Employer Matching benefit); Paid Time Off (Rollover Option) and Holidays; As Needed Sick Time; Tuition Reimbursement; Team Social Activities (We have fun!); Employee Recognition; Employee Referral Program; Paid Parental Leave and Bereavement