Lead CQV Validation Engineer - Frederick, MD
*All applicants must be authorized to work in the United States. We are not currently accepting work visas.*
One of my clients is seeking a highly skilled Lead CQV Validation Engineer to join their team. This role is crucial for ensuring regulatory compliance and successful validation processes within the life sciences sector. The ideal candidate will have extensive experience in managing large-scale projects, leading diverse teams, and maintaining high standards of quality and compliance.
Their growth is driven by exceptional individuals who excel in a collaborative environment and share our mission to enhance lives. Our dedicated professionals strive to make a difference every day.
Company Culture & Values:
- Empower and support colleagues.
- Commit to client success.
- Have the courage to do the right thing.
- Foster an inclusive, respectful, and engaging environment.
- Continuously learn and enhance collective expertise.
Lead CQV Engineer Responsibilities:
- Consult on regulatory validation processes and industry practices.
- Support validation audits and remediation efforts.
- Serve as a subject matter expert in system compliance and validation.
- Manage capital equipment procurement, installation, and validation.
- Oversee multiple projects and clients.
- Lead client-facing activities and manage issues.
- Work with equipment OEMs and installation vendors.
- Design validation plans.
- Conduct and document impact and risk assessments.
- Maintain detailed records for compliance audits.
Requirements:
- Strong understanding of validation processes and regulatory requirements (GMP, FDA, EMA).
- Experience leading C&Q efforts on large-scale projects.
- Proven track record of managing diverse teams.
- Knowledge of industry best practices for commissioning and qualification.
- Commitment to being on-site; local candidates preferred.
- Excellent communication and collaboration skills.
Benefits:
- High growth potential and people-focused culture.
- Competitive pay and performance-based incentives.
- 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).
- Paid Time Off and Holidays.
- Sick Time as needed.
- Tuition Reimbursement.
- Team Social Activities.
- Employee Recognition.
- Employee Referral Program.
- Paid Parental Leave and Bereavement.
