Engineering Manager (Compliance)

The Role

The Engineering Compliance Manager manages a team of professionals responsible for compliance to regulatory and governing documents and practices within the Engineering and Maintenance departments. This position oversees closure of open gaps and drives improvement. This position reports to the Director of Engineering.

Responsibilities

• Partners cross-functionally across Engineering, Maintenance, and Quality to drive open E&M owned corrective actions to closure without repeat occurrences. Facilitates governance for CAPA and finding closures. Tracks and reports progress, risks, and resource needs to leadership.
• Drives and maintain Audit Readiness; ensure compliance with procedures and maintain facility/site drawings
• Manages a team responsible for deviation investigation, corrective actions, and on-time closure for batch release.
• Collaborates with vendors and internal personnel to ensure adherence to pest control standards. Responsible for ensuring monthly pest control reports and trending analysis. Analyze trends and implement corresponding facility improvements.
• Reporting team facilitates asset creation in ERP system, SOP revision, and engineering documentation review and approval
• Ensures compliance to procedures and reviews practices, including logbook reviews and vendor checks
• Author, review, and approval protocols, reports, deviation investigations, change controls, and CAPAs related to CQV scope
• Support regulatory inspections and client audits
• Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans

Requirements (Education, Experience & Qualifications)

• BS degree in Engineering, Life Sciences, or related technical field
• 8+ years experience in pharmaceutical/biotech industry preferred
• Excellent oral and written communication skills with the ability to influence cross-functional teams
• Strong organizational, planning, and project tracking skills
• Ability to manage multiple priorities in a fast-paced environment

In return, you’ll be eligible for:

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Short and Long-Term Disability Insurance
• Voluntary Insurance Benefits
• Vision Coverage
• Accident
• Critical Illness
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal and more
• Onsite Campus Amenities
• Workout Facility
• Cafeteria
• Credit Union

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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