Manufacturing Process Technician

Job DescriptionJob Description

CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.

Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

EQUAL OPPORTUNITY EMPLOYER

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.

SUMMARY

The Manufacturing Process Technician is responsible for the safe manufacture of pharmaceutical intermediates and APIs within one of the Corden Pharma Colorado Manufacturing Centers of Excellence. The Technician performs various unit operations on raw materials and intermediates according to written manufacturing procedures and SOPs. The Technician is familiar with hands-on operation of manufacturing process equipment and material handling. The Technician prepares equipment for maintenance and maintains a consistent high level of housekeeping. The Technician displays initiative in completing assigned tasks, the ability to think ahead to prepare for the next steps in processing; and displays a high level of attention to detail and accuracy in their work.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Establishes and maintains strong, transparent, and effective day-to-day working relationships between Manufacturing, Maintenance & Facilities, R&D, internal support, regulatory groups, and CPC customers related to assigned duties
• Work closely with fellow crew members, supervision, and support groups to safely achieve manufacturing goals
• Demonstrate progressive understanding of plant equipment, plant infrastructure systems, and chemical processing principles in one or more CPC Centers of Excellence
• Thoroughly follows written procedures; accurately and completely documents operations as executed according to cGMP and Corden Pharma Colorado SOPs
• Double checks the work of other operators
• Demonstrates the ability to set up and perform operations properly and efficiently, along with understanding computer systems (DCS, LIMS, etc.) related to standard operations in the area
• Receives Emergency Brigade training and participates in the brigade as hazmat technical, firefighter, and first aid responder, including EMT and/or full emergency brigade member
• Trained in First Aid/CPR
• Respond as appropriate to plant upset and/or emergency situations as a brigade member
• Demonstrate ability to detect and respond to potential hazards and/or emergency situations in daily operations
• Attends all required GMP training sessions and displays an understanding of current Corden GMP, SOPs, and Chemical Operator Training Program
• Adheres to housekeeping and safety practices; participates in safety programs offered through the organization
• Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste, and monitors plant environmental systems
• Perform training sessions for subordinate/peers within the work environment to accurately meet production needs and timing
• Read and comprehend safety rules and instructions in the use of maintenance, in the use of shop tools and equipment, and in methods and procedures in mechanical drawing and layout work
• Activities may include structural demolition of buildings and equipment with focus on dismantling and salvage

LEADERSHIP & BUDGET RESPONSIBILITIES

None.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

High school diploma or General Education Degree (GED); and 3 months related experience and/or training.

LANGUAGE SKILLS

Ability to read and interpret technical documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to contribute to meetings and work effectively with others.

MATHEMATICAL SKILLS

Ability to add, subtract, multiply, divide, and round accurately in all units of measure, using whole numbers, common fractions, and decimals. Ability accurately to compute rate, ratio, and percent, and to understand the metric system.

REASONING ABILITY

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Ability interpret data and troubleshoot processes based on available data and process performance.

CERTIFICATES, LICENSES, REGISTRATIONS

Not mandatory. However, forklift certification is a plus.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is required to regularly climb stairs or ladders, to stand; walk; work with hands; climb or balance; talk or hear; and taste or smell. The employee frequently is required to reach above shoulder height. The employee is occasionally required to sit and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Able to engage in all forms of physical labor necessary for the completion of construction/demolition projects; to include awkward and repetitive manual tasks that could require forceful exertion.

Required to wear basic PPE during work (hard hat, safety glasses, safety boots, and uniform). Required to wear full PPE (i.e., respiratory protection and chemical resistant garments, etc.) as necessary.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly exposed to moving mechanical parts. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; fumes or airborne particles; low levels of toxic or caustic chemicals; outside weather conditions; uncomfortable extremes of temperature; and vibration. The noise level in the work environment is usually moderate.

CORE COMPETENCIES

These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.

• Knowledge of chemical processing
• Ability to learn and retain technical concepts through observation, discussion, and in-field practice
• Excellent verbal and written communication skills
• Demonstrated mechanical aptitude - industry related
• Strong computer, math, reading, and comprehension skills
• Ability to work on 12 hour rotating shifts, night or day, weekends, and holidays required
• Dependable and reliable work ethic; willing to accept increased responsibility
• Ability to learn and demonstrate safety and regulatory compliance practices appropriate to assigned tasks
• Strong interpersonal skills and ability to work in a team environment
• Highly motivated – demonstrates initiative
• Ability to troubleshoot
• High attention to detail
• Ability to work independently, as well as working within a team
• Detailed knowledge of plant equipment and infrastructure systems
• Performs a necessary function on the Corden Pharma Colorado Emergency Brigade
• Manual dexterity with knowledge and ability to work with construction and demolition equipment; to include the potential to operate hand and power tools of all types

SALARY

Actual pay will be based on your skills and experience.

BENEFITS

• 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
• Accident Plan
• Critical Illness
• Dental Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft
• Life Insurance
• Paid Maternity/Paternity Leave
• Tuition Reimbursement
• Wellness Program
• Vacation – Three Weeks 1st Year
• Vision Insurance

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