BioSpace
Validation Area Specialist II - Virginia
BioSpace, Virginia State University, Virginia, us, 23806
Overview
Validation Area Specialist II – Virginia at BioSpace is a full‑time, mid‑senior position focused on ensuring the quality and compliance of processes and equipment in a chemistry API environment. The role involves performing and overseeing validation activities, supporting change requests, and collaborating with cross‑functional teams. What We Offer You
Competitive salary and annual performance bonus Paid time off including 14 paid holidays Health, dental and vision insurance effective day one Guaranteed 8% 401(k) contribution with company match option Family‑focused benefits including 14 weeks paid parental leave and 6 weeks paid family medical leave Free access to Novo Nordisk‑marketed pharmaceutical products Tuition assistance Life & disability insurance Employee referral awards The Position
Plan, manage, and perform moderately complex or cross‑functional validation activities and projects. Support engineers with writing change requests, conducting/writing deviation investigations, and supporting validation activities associated with changes to existing and new systems. Process equipment supported includes propagation, fermenters, media sterilizers and supporting equipment. Relationships
Reports to Manager, Director. Essential Functions
Perform, review, and approve validation, revalidation, and PSE activities. Identify and support/perform remediation of validation compliance gaps for the department. Review and approve documents in accordance with local, corporate, and regulatory regulations. Collaborate, review, and approve protocols for systems/processes per approved timeframes. Lead the closure of investigations using root cause analysis techniques. Ensure protocol data is accurate, meets acceptance criteria, and supports reoccurrence elimination. Manage Change Requests related to revalidation and other validation activities. Create, review, and approve validation procedures, specifications, and quality documents for accuracy and compliance. Present and support validation concepts and approaches during audits and inspections. Lead and manage relevant validation projects and change control processes, identifying improvement opportunities. Write, review specifications, procedures, & other documents to maintain validated state of equipment and processes. Coach, mentor, and train junior specialists. Operate in alignment with NNWay, demonstrating a Quality & cLEAN® Mindset. Follow all safety & environmental requirements in performance of duties. Physical Requirements
Ability to work in an open office environment with frequent distractions. Travel up to 10% of the time (may vary). Ability to lift or move equipment as required. Qualifications
Bachelor’s degree in engineering, pharmaceutical sciences or related field from an accredited university (minimum five years of related validation experience). Associate’s degree with a minimum of seven years of validation experience may be considered. High school diploma with a minimum of nine years of validation experience may be considered. Experience in quality concepts, technical & compliance review of validation & quality documents. Experience in core validation areas (equipment, sterilization, cleaning, process, or computer validation) preferred. Experience in cGMP documentation practices & regulations. Basic computer skills (Microsoft Word, Excel). Knowledge of statistical methods preferred. Strong oral & written communication skills. Experience with validation test equipment (e.g., temperature mapping equipment). Experience working in cross‑functional teams. Demonstrated experience using root‑cause analysis techniques. We commit to an inclusive recruitment process and equal opportunity for all applicants. Novo Nordisk is an equal opportunity employer. Qualified applicants will be considered without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by law.
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Validation Area Specialist II – Virginia at BioSpace is a full‑time, mid‑senior position focused on ensuring the quality and compliance of processes and equipment in a chemistry API environment. The role involves performing and overseeing validation activities, supporting change requests, and collaborating with cross‑functional teams. What We Offer You
Competitive salary and annual performance bonus Paid time off including 14 paid holidays Health, dental and vision insurance effective day one Guaranteed 8% 401(k) contribution with company match option Family‑focused benefits including 14 weeks paid parental leave and 6 weeks paid family medical leave Free access to Novo Nordisk‑marketed pharmaceutical products Tuition assistance Life & disability insurance Employee referral awards The Position
Plan, manage, and perform moderately complex or cross‑functional validation activities and projects. Support engineers with writing change requests, conducting/writing deviation investigations, and supporting validation activities associated with changes to existing and new systems. Process equipment supported includes propagation, fermenters, media sterilizers and supporting equipment. Relationships
Reports to Manager, Director. Essential Functions
Perform, review, and approve validation, revalidation, and PSE activities. Identify and support/perform remediation of validation compliance gaps for the department. Review and approve documents in accordance with local, corporate, and regulatory regulations. Collaborate, review, and approve protocols for systems/processes per approved timeframes. Lead the closure of investigations using root cause analysis techniques. Ensure protocol data is accurate, meets acceptance criteria, and supports reoccurrence elimination. Manage Change Requests related to revalidation and other validation activities. Create, review, and approve validation procedures, specifications, and quality documents for accuracy and compliance. Present and support validation concepts and approaches during audits and inspections. Lead and manage relevant validation projects and change control processes, identifying improvement opportunities. Write, review specifications, procedures, & other documents to maintain validated state of equipment and processes. Coach, mentor, and train junior specialists. Operate in alignment with NNWay, demonstrating a Quality & cLEAN® Mindset. Follow all safety & environmental requirements in performance of duties. Physical Requirements
Ability to work in an open office environment with frequent distractions. Travel up to 10% of the time (may vary). Ability to lift or move equipment as required. Qualifications
Bachelor’s degree in engineering, pharmaceutical sciences or related field from an accredited university (minimum five years of related validation experience). Associate’s degree with a minimum of seven years of validation experience may be considered. High school diploma with a minimum of nine years of validation experience may be considered. Experience in quality concepts, technical & compliance review of validation & quality documents. Experience in core validation areas (equipment, sterilization, cleaning, process, or computer validation) preferred. Experience in cGMP documentation practices & regulations. Basic computer skills (Microsoft Word, Excel). Knowledge of statistical methods preferred. Strong oral & written communication skills. Experience with validation test equipment (e.g., temperature mapping equipment). Experience working in cross‑functional teams. Demonstrated experience using root‑cause analysis techniques. We commit to an inclusive recruitment process and equal opportunity for all applicants. Novo Nordisk is an equal opportunity employer. Qualified applicants will be considered without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by law.
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