Simtra BioPharma Solutions
Environmental Monitoring Supervisor (weekend 2nd)
Simtra BioPharma Solutions, Bloomington, Indiana, United States, 47401
Bloomington, Indiana, United States
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. 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 Environmental Monitoring Supervisor leads the daily operations of the Environmental Monitoring functional department or quality system. The supervisor serves as the leader of their respective area and is a critical member of the Microbiology leadership team. The working hours for this role are Friday, Saturday, and Sunday 12:00pm-12:30am. The responsibilities: Provides guidance, support, direction and leadership to Quality Technicians through positive interactions with all personnel during daily operations. Prioritizes workloads and assigns duties/shift requirements based on company needs. Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans. Sets local departmental policy and goals, and implement plans and systems to meet those goals. Participates in the Microbiology leadership team to build systems and set goals and policy for the Microbiology department. Participates in audits and as part of cross-functional teams with other Baxter departments and facilities as the SME (Subject Matter Expert) of the department supervised. Writes and reviews investigations for out of level results, and other microbiology related investigations as appropriate. Performs statistical analysis of data and evaluates the area supervised for microbiological trends, and responds appropriately. Bachelor’s degree in a physical science required, preferably in Microbiology Minimum of 2 years of experience in Quality required 1 year of leadership experience required Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.) Physical / safety requirements: Must be able to gown qualify for Grade A/B area. The position sometimes requires extended periods of standing. Must be able to wear applicable Personal Protective Equipment. Position may require handling laboratory chemicals. Duties may require overtime work, including nights and weekends Use of hands and fingers to manipulate office equipment is required In return, you’ll be eligible for [1] : 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
[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. 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 To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: Interested in building your career at Simtra BioPharma Solutions? Get future opportunities sent straight to your email. Apply for this job
* indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Education Degree * Select... What are your annual salary expectations? * Do you have a minimum of a bachelors degree in a physical science (microbiology, biology, chemistry, etc.)? * Select... Are you currently authorized to work in the country you are applying for?* * Select... Will you now or in the future require sponsorship? * Select... Where are you currently located? * Please list city and state. Please review the Simtra Privacy Notice and select that you have read and acknowledged the policy using the dropdown box below. * Select... Please list street, APT/Unit #, city, state, and zip code. SMS Consent: Do you agree to receive mobile messages from us in relation to this job application? Message frequency varies. Message and data rates may apply. Reply STOP to opt-out of future messaging. Reply HELP for help. View our Privacy & SMS Policy: * Select... For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Simtra BioPharma Solutions’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability
Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury
Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
#J-18808-Ljbffr
Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. 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 Environmental Monitoring Supervisor leads the daily operations of the Environmental Monitoring functional department or quality system. The supervisor serves as the leader of their respective area and is a critical member of the Microbiology leadership team. The working hours for this role are Friday, Saturday, and Sunday 12:00pm-12:30am. The responsibilities: Provides guidance, support, direction and leadership to Quality Technicians through positive interactions with all personnel during daily operations. Prioritizes workloads and assigns duties/shift requirements based on company needs. Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans. Sets local departmental policy and goals, and implement plans and systems to meet those goals. Participates in the Microbiology leadership team to build systems and set goals and policy for the Microbiology department. Participates in audits and as part of cross-functional teams with other Baxter departments and facilities as the SME (Subject Matter Expert) of the department supervised. Writes and reviews investigations for out of level results, and other microbiology related investigations as appropriate. Performs statistical analysis of data and evaluates the area supervised for microbiological trends, and responds appropriately. Bachelor’s degree in a physical science required, preferably in Microbiology Minimum of 2 years of experience in Quality required 1 year of leadership experience required Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.) Physical / safety requirements: Must be able to gown qualify for Grade A/B area. The position sometimes requires extended periods of standing. Must be able to wear applicable Personal Protective Equipment. Position may require handling laboratory chemicals. Duties may require overtime work, including nights and weekends Use of hands and fingers to manipulate office equipment is required In return, you’ll be eligible for [1] : 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
[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. 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 To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: Interested in building your career at Simtra BioPharma Solutions? Get future opportunities sent straight to your email. Apply for this job
* indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Education Degree * Select... What are your annual salary expectations? * Do you have a minimum of a bachelors degree in a physical science (microbiology, biology, chemistry, etc.)? * Select... Are you currently authorized to work in the country you are applying for?* * Select... Will you now or in the future require sponsorship? * Select... Where are you currently located? * Please list city and state. Please review the Simtra Privacy Notice and select that you have read and acknowledged the policy using the dropdown box below. * Select... Please list street, APT/Unit #, city, state, and zip code. SMS Consent: Do you agree to receive mobile messages from us in relation to this job application? Message frequency varies. Message and data rates may apply. Reply STOP to opt-out of future messaging. Reply HELP for help. View our Privacy & SMS Policy: * Select... For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Simtra BioPharma Solutions’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability
Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury
Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
#J-18808-Ljbffr