Digital Transformation Architect (OPEX)
Apply NowCompany: Simtra BioPharma Solutions
Location: Bloomington, IN 47401
Description:
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 Bloomington facility is a full-service contract manufacturing plant providing formulation, aseptic filling, and finish services. Through the implementation of lean principles this position supports the organization by transforming challenges into value-added business results and value creation for customers.
As a core member of the Operational Execution team, the Digital Transformation Architect will drive process improvement at the site through the development, deployment, and integration of digital solutions. This individual should be a strong team player with highly developed communication and problem-solving skills. This position reports to the Associate Director of Operation Execution.
The responsibilities:
The work environment:
Desirable qualifications:
Physical / safety requirements:
In return, you'll be eligible for [1]:
[1] Current benefit offerings are in effect through 12/31/24
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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:
https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy
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 Bloomington facility is a full-service contract manufacturing plant providing formulation, aseptic filling, and finish services. Through the implementation of lean principles this position supports the organization by transforming challenges into value-added business results and value creation for customers.
As a core member of the Operational Execution team, the Digital Transformation Architect will drive process improvement at the site through the development, deployment, and integration of digital solutions. This individual should be a strong team player with highly developed communication and problem-solving skills. This position reports to the Associate Director of Operation Execution.
The responsibilities:
- Supports and drives key OPEX programs at the site (OEE, Capacity Unlock, RFT, OTD)
- Organizes, oversees, and reports out on progress of key project implementations with regards to new digital solutions and technologies
- Works as liaison with customers and suppliers to identify potential enhancements to current processes through use of digital technologies
- Facilitates problem-solving for key gaps in plant performance expectations
- Stays current on technological advancements in the pharmaceutical manufacturing/aseptic processing to identify potential improvement opportunities
The work environment:
- BS degree required, preferably in science or engineering related field
- 2+ years of pharmaceutical industry experience
- Experience managing projects from ideation to implementation
- Ability to manage multiple projects and work with cross-functional teams
- Experience with customer/client facing
- Strong negotiating and influencing skills
- Strong analytical/statistical problem-solving skills and experience using appropriate tools (i.e., Minitab, PowerBI, etc.)
- Strong communication (oral and written) skills
- Intermediate or higher computer proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
- Experience using Enterprise software systems (i.e., electronic document management, Trackwise, etc.)
Desirable qualifications:
- BS degree required, preferably in science or engineering related field
- 2+ years of pharmaceutical industry experience
- Experience managing projects from ideation to implementation
- Ability to manage multiple projects and work with cross-functional teams
- Experience with customer/client facing
- Strong negotiating and influencing skills
- Strong analytical/statistical problem-solving skills and experience using appropriate tools (i.e., Minitab, PowerBI, etc.)
- Strong communication (oral and written) skills
- Intermediate or higher computer proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
- Experience using Enterprise software systems (i.e., electronic document management, Trackwise, etc.)
Physical / safety requirements:
- Ability to meet Grade C gowning requirements
- Duties may require overtime work, including nights and weekends
- Use of hands and fingers to manipulate office equipment is required
- Position requires sitting for long hours, but may involve walking/standing for periods of time
In return, you'll be eligible for [1]:
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- Short and Long-Term Disability 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
- Additional Benefits
- 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
- Voluntary Insurance Benefits
[1] Current benefit offerings are in effect through 12/31/24
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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:
https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy