Engineering Manager (Compliance)

Engineering Manager (Compliance)Bloomington, Indiana, United StatesSimtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.

Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.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.The Responsibilities:The Compliance Manager 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 drawingsManages 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 approvalEnsures compliance to procedures and reviews practices, including logbook reviews and vendor checksAuthor, review, and approval protocols, reports, deviation investigations, change controls, and CAPAs related to CQV scopeSupport regulatory inspections and client auditsInterviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports.

Assist in setting performance objectives and development plansThe Requirements (Education, Experience & Qualifications):BS degree in Engineering, Life Sciences, or related technical field8+ years experience in pharmaceutical/biotech industry preferredExcellent oral and written communication skills with the ability to influence cross-functional teamsStrong organizational, planning, and project tracking skillsAbility to manage multiple priorities in a fast-paced environmentIn return, you'll be eligible for:Day One BenefitsMedical & Dental CoverageFlexible Spending AccountsLife and AD&D InsuranceSupplemental Life InsuranceSpouse Life InsuranceChild Life Insurance401(k) Retirement Savings Plan with Company MatchTime Off ProgramPaid HolidaysPaid Time OffPaid Parental Leave and moreAdoption Reimbursement ProgramEducation Assistance ProgramEmployee Assistance ProgramCommunity and Volunteer Service ProgramEmployee Ownership PlanAdditional BenefitsShort and Long-Term Disability InsuranceVoluntary Insurance BenefitsVision CoverageAccidentCritical IllnessHospital Indemnity InsuranceIdentity Theft ProtectionLegal and moreOnsite Campus AmenitiesWorkout FacilityCafeteriaCredit UnionCurrent benefit offerings are in effect through 12/31/26This 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.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.To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy.