Simtra BioPharma Solutions

Pharmaceutical Manufacturing Supervisor, (2nd Shift)

Bloomington, Indiana, United States · Staff+

Sponsorship not specifiedDetected 12 days ago

ExcelAuditingProcess ImprovementPerformance ManagementCustomer SupportGMPLeadershipMicrosoft Office

About the role

The Supervisor, Aseptic Operations is a member of the Operations Leadership Team and reports directly to the Manager, Aseptic Operations.
Hours: Monday - Thursday 3:00pm- 12:00am
The Supervisor, Aseptic Operations provides decision making and oversight to ensure compliance to all standard operating procedures and batch records.

Understand, follow, coach, and lead their teams to execute production activities in accordance with current Good Manufacturing Practices (cGMP).
Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.
Implement and support training programs designed to enable staff to consistently carry out all manufacturing processes with strict compliance to cGMPs and EHS regulations.
Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operational efficiency and quality. Implement changes as needed based on assessments.
Lead technical reviews, investigations and process improvement projects. Provide manufacturing input into integration and validation of new equipment and processes.
Obtain qualification to perform select critical operation processes.
Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Ability to stand or sit for extended periods of time
Ability to lift up to 50 pounds
Ability to push/pull heavy wheeled objects (i.e.: tanks, carts, pallet jacks, etc.)
Must be able to perform overhead work (i.e.: sanitizing walls and ceilings)
Ability to wear respirator usage when product or task requires
Use of hands and fingers to manipulate office equipment is required
Must be able to gown qualify for Grade A/B areas (filling)
High School diploma or GED required
Minimum 2 years of manufacturing or operations support experience required
Minimum 1 year leadership experience required
Computer proficiency in Microsoft Word,

Bachelor's Degree in a science, engineering, or business discipline strongly preferred

Interview, hire, mentor, and develop staff. Conduct annual performance reviews for all direct reports. Assists in setting performance objectives and development plans.

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.
Day One Benefits
Medical & Dental Coverage
Flexible Spending Accounts
Supplemental Life Insurance
Spouse Life Insurance
Child Life Insurance
401(k) Retirement Savings Plan with Company Match
Time Off Program
Paid Parental Leave and more
Adoption Reimbursement Program
Education Assistance Program

Represent the company during audits and inspections.
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.

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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