Commissioning & Qualification Manager

Simtra 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.

Why join Team Simtra?Because we:


Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.

Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.

This role:


The Commissioning & Qualification Manager position is responsible for ensuring production, utilities and related equipment and systems are qualified and validated in accordance with Simtra requirements, policies, and procedures. In addition, this role is responsible for driving the effective and consistent use of the best Commissioning, Qualification, and Validation (CQV) practices used in the industry. This role provides leadership to the Engineering & Technology department and to the site to ensure qualification and validation standards are being met. This position is onsite daily at the Bloomington facility and reports to the Director of Engineering & Technology.

The responsibilities:

• Accountability for activities involved in the evaluation, review and approval of validation project plans, validation protocols and reports, and other validation lifecycle documentation
• Lead a team of full-time and contract Validation Engineers to provide guidance on planning, scheduling, and execution of validation activities
• Provide technical & tactical guidance to the validation team, completing performance management actions and regular 1:
  1 meetings with individuals on the team
• Develop and evaluate quality process and system standards to ensure compliance with company standards and governmental regulatory requirements
• Manage multiple projects/ongoing work activities within the department typically involving cross-functional teams
• Investigate & troubleshoot validation problems for equipment and/or performance processes, conducting statistical analyses of testing results and process anomalies
• Write, review, approve and/or implement documentation for new and current validation procedures and technical reports related to equipment, products and/or processes
• Plan and oversee the execution of validation and improvement project activities following applicable regulatory and Simtra requirements and ensure applicable Validation Master Plans (VMPs) and documents are maintained to cGxP compliance
• Implements department strategy, by leading cross functional projects in the design or redesign of projects
• Ensure that appropriate systems are in place such that site operations meet or exceed the requirements
• Provide leadership to site technical staff regarding the development of validation strategies and validation master plans for equipment, facilities, utilities, and manufacturing equipment
• Maintain all infrastructure and compliance documentation for the facility for the purpose of maintaining regulatory compliance with Contractual, Procedural, Federal, State or Local law requirements
• Present validation packages to boards of health/regulators & internal inspections
• Allocate department staffing and manage the utilization of facilities and equipment to ensure that department and site objectives are met within budget guidelines
• Establish governance and contributor accountability for timely project completion
• Develop, introduce, and review practices and cultural changes that enable the department to meet business demands within agreed timeframes and expected regulatory standards
• Provide leadership to vendors, staff and service providers as required to ensure that compliance expectations and adoption of best practices are communicated and followed

• BS degree in engineering with 5+ years (OR MS degree in engineering with 2+ years) of experience in equipment, process, utilities, or facilities commissioning, qualification, and validation within the pharmaceutical industry - in lieu of BS degree in engineering, a BS degree in a scientific discipline with 10+ years of relevant experience in in equipment, process, utilities, or facilities commissioning, qualification, and validation within the pharmaceutical industry
• 4+ years of relevant people management and leadership experience of engineers and/or scientists
• Extensive understanding and knowledge of regulatory requirements and validation as applied to the pharmaceutical equipment and facilities
• Good understanding of risk management methodologies, with a proven ability to apply to pharmaceutical operations
• Excellent written and verbal communication skills with the ability to interact with senior leadership and regulatory agencies
• Good organizational, presentation, meeting facilitation, project/time management, and conflict resolution skills technical writing skills
• Strong analytical and problem-solving abilities
• Demonstrated application of cGMPs and regulatory requirements as they apply to the pharmaceutical field
• Understanding of engineering concepts
• Understanding of use of best practices in the life sciences industry
• Strong oral and written communication skills, i. e. , effective presentation of concepts and ideas and technical writing skills
• Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams) and Adobe Acrobat

• Ability to obtain A/B and C/D gowning access
• Ability to stand and walk for prolonged periods of time

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insur.