Aseptic Process Engineer Jobs in Colorado (NOW HIRING)

Core Hours: 

• Wednesday - Saturday (every other Wednesday off), 6:00 pm - 6:30 am
• Training schedule may vary. 

Purpose and Scope

The Production Maintenance Supervisor is responsible for the overall supervision, planning, scheduling and follow-up activities of the maintenance of the production and packaging equipment and aseptic processes. Provide technical support for general manufacturing and aseptic process areas.

Essential Duties & Responsibilities

• Work in conjunction with the Maintenance Manager to direct activities to ensure operational readiness of all Tolmar facilities and equipment, within budget and in compliance with established regulations.
• Manage all production maintenance systems and personnel to ensure all work orders are completed within the parameters of the plant-wide work order system in a timely and quality manner.
• Hire, train, supervise, counsel and evaluate direct-report employees; conduct and submit annual performance appraisals; recommend/authorize pay adjustments as appropriate.
• Establish training program for Production Maintenance Technicians in collaboration with Maintenance Manager.
• Responsible for maintaining spare parts inventory for assigned equipment, including monitoring levels, initiating requisitions, completing budget review, and ordering necessary materials.
• Assist with quality event investigations and company audits.
• Assist in facility layout and design for newer processes areas and expansion at other facilities.
• Ensure the development and adherence to all production equipment preventative maintenance schedules.
• Contract with outside service providers for various facility and equipment-related maintenance needs.
• Provide recommendations to executive management to resolve maintenance issues and operation improvement.
• Maintain process equipment and machinery and perform scheduled maintenance operations.
• Responsible for engineering support and maintaining equipment and processes to include the construction, modification and improvement of equipment utilizing direct reports.
• Responsible for training and directing Maintenance Technician I, II and III staff in production equipment operation, set-ups and repairs.
• Responsible for training maintenance and production employees on the use, maintenance and cleaning of equipment.
• Responsible for maintaining content of training records for department in compliance with cGMP standards.
• Develop and maintain successful working relationships with both internal and external clients.
• Assist Maintenance Manager with preparation of budget for department and monitor adherence to budget
• Ensure the department’s compliance to established company safety policies and procedures. Be an advocate for safety programs.
• Represent the production maintenance department at company meetings as necessary.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to the handling of universal waste such as spent fluorescent tubes, spent filters, batteries, and used oil. Responsible for daily activities and supervising staff that are universal hazardous waste generators and/or handlers. Respond to spills per CP 030-0202 Chemical Spill Response.
• Perform other duties as assigned.

Knowledge, Skills & Abilities 

• Working knowledge of current Good Manufacturing Practices (cGMP) and/or ISO 9001 equipment requirements.
• Working knowledge of cGMP requirements.
• Knowledge of maintenance functions in a FDA regulated facility.
• Strong supervisory skills, coupled with excellent oral and written communication skills.
• High mechanical aptitude; ability to analyze the mechanics of new equipment for the most efficient outcome.
• Overall technical competencies necessary to manage and direct skilled maintenance technicians.
• Procedure writing and review skills.
• Computer skills include Word, Excel, and PM scheduling.
• Demonstrated ability to work efficiently under conditions of multiple deadlines and changing priorities in production.
• Ability to problem-solve a broad range of technical issues.
• Ability to plan and work with supporting technical resources such as internal engineers and scientists as well as contract support and external suppliers and consultants.
• Valid driver’s license and acceptable MVR required.

Core Values

• The Production Maintenance Supervisor is expected to operate within the framework of Tolmar’s Core Values:
• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile:  We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically:  We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve:  We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable:  We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• Bachelor’s degree or equivalent combination of education and experience.
• Five years maintenance experience in a regulated industry, preferably in the manufacture of sterile drug products and/or medical devices.
• At least 2 years of supervisory experience preferred.
• Experience utilizing an automated PM scheduling, work order, spare parts, and calibration software package (Maximo preferred); cGMP audit management preferred.

Working Conditions

• Manufacturing environment including general manufacturing and aseptic process areas. Work may require occasional weekend and/or evening work.

Compensation and Benefits

• Pay: $95,000 - $100,000 depending on experience
• Shift differential: 15%
• Bonus eligible
• Benefits summary:  https://www.tolmar.com/careers/employee-benefits 

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience. 

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.