The Validation Engineer reports directly to the Manager of Validation. The role is responsible for acting as a Subject Matter Expert (SME) for the Commissioning, Qualification, and Validation (CQV) processes for the site. This includes commissioning and qualification of the equipment, process validation, facilities qualification, utilities qualification, electronic system validation, shipping validation, and program maintenance. This role ensures all systems operate within regulations to ensure the production of quality products.
Essential Functions:This description is intended to be illustrative of the major duties performed by the employee assigned to this position.
- Works on projects/matters in a supporting capacity. Communication may be directed towards the project team and direct management, or the audience may be a wider cross-functional group.
- Work alongside commissioning agents to complete initial facility qualification and bring systems and processes online.
- Utilizes Project Management skills to plan and coordinate efforts with a cross-functional team.
- Completes tasks in a timely fashion and communicate task status to management and/or project team.
- Adheres to GDP/GMP guidelines to author, review, or support technical documents including but not limited to change controls, and CAPAs.
- Coordination of Validation activities with stakeholders.
- Support in writing and executing protocols for Validation work.
- Identifies and resolves non-conformances/discrepancies encountered during IQ/OQ/PQ execution and work with cross function team to implement mitigation solutions.
- Generate reports and summarize results, including confirming the document is suitable to be shared with regulatory agencies.
- Supports creation or revision of Validation templates for protocols and reports.
- Supports creation and review of Engineering Documentation (URS, FS, SAT, FAT).
- Act as a subject matter expert for all site qualification and validation activities.
- Supports project work as a specialist on complex technical matters.
- Mentoring of less experienced team members.
- Other duties as assigned.
Supervisory Responsibilities: Experience & Necessary Competencies- Bachelor's degree in a STEM field required; i.e. engineering, chemistry, or relevant industry experience.
- 4+ years of validation experience, preferably in a highly regulated environment.
- Experience in project management preferred
- Demonstrated ability to conduct statistical analysis using software (JMP, MiniTab, Saas, etc.)
- Strong curiosity and willingness to learn, along with the tenacity and drive to see projects through.
- Willingness to support tasks outside normal job description, as needed. Can-do attitude!
- Ability to create technical and professional documents.
- Strong attention to detail and accuracy.
- Ability to multi-task, with strong organization and time-management.
- Ability to work under pressure and independently with the ability to make decisions according to established guidelines and accomplish tasks accurately and on a timely basis.
- Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus!
- Proficient written, verbal and oral English communication skills are required.
- Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.
Physical Requirements:- Ability to stand or sit for extended periods of time.
- Ability to lift, push and pull up to 50 pounds periodically.
- Ability to maintain a gowning qualification and adhere to aseptic practices.
Benefits:- Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
- Flexible Spending & Health Savings Accounts (FSA & HSA) available
- Dental & Vision insurance
- Employer Paid Life Insurance & Employee Assistance Program
- Short Term & Long-Term Disability Insurance
- Up to 4% 401K Matching (100% vested on day one!)
- Generous Paid Time Off Options - vacation, sick, paid leave and holidays!
- $5,250 Annual Tuition Reimbursement after 6 months
- $1,000 Referral Bonus Program with no limit
- Eligible for annual bonus program
Timeline: We will be accepting applications on an ongoing basis until position is filled.
*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.
