Lead Formulation Technician

PURPOSE AND SCOPE:

Provide technical direction in relation to formulations process and assist Supervisor. Responsibilities include training employees, planning, assigning, and directing work, resolving problems and interfacing between employees, supervisor, and leads of other production lines. Perform all shift supervisory roles in the event of the Supervisor’s absence.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Follow and enforce all clean room procedures including gowning technique and hand washing.
• Maintain a high level of proficiency in regard to troubleshooting formulations equipment issues and errors within system.
• Conduct daily duties as the subject matter expert of the formulations department. Verify process controls are met within parameters defined within SOPs.
• Monitor individual employee performance and assists employees needing additional training.
• Notify supervisor of general operations issues or problems.
• Write validation protocols, technical reports, standard operating procedures, and test methods.
• Perform validations within formulations department.
• Works on assignments requiring considerable judgment and initiative. Understands implications of work and makes recommendations for solutions.
• Contacts are frequently with individuals representing other departments, individuals representing outside organizations, and individuals of significant importance within the company. Contacts involve planning and preparation of the communications; requires skill, tact, persuasion and/or negotiation to accomplish the objectives of the communications.
• Review, route, and implement CCR as per established procedures.
• May act as an informal team leader and provides assistance to formulations technicians and junior level staff with support tasks that require considerable judgment and initiative.
• Other Technicians look to this position as well as supervisory/management positions for technical information, skills and leadership.
• Train formulation personnel on new processes and/or process changes.
• Maintain current GMP standards and operation procedures.
• Perform preventative maintenance within formulations department.
• May initiate work orders pertaining to formulations department.
• Perform NC’s pertaining to formulations department.
• Complete BPR’s fully and accurately in addition to reviewing completed BPR’s or other documentation as it pertains to the formulation process.
• Follow all Fresenius Policies.
• Regular attendance and maintaining a good attendance record is an essential function of the job.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• May escalate difficult/complex issues to supervisor for resolution, as deemed necessary.
• Assist with various projects as assigned by direct supervisor.
• Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

• The physical demands and 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 noise level in the work environment is usually loud.

• While performing the duties of this job, the employee is regularly required to wear personal protective equipment that may include safety shoes, safety glasses, hair net, Solution bunny suit, etc. The employee is frequently required to walk. The employee is occasionally required to stand; sit; use hands and fingers to handle,; reach with hands and arms; climb or balance; stoop, kneel, or crouch, and talk or hear. The employee must regularly life and/or move 10 to 25 pounds, frequently lift and/or move up to 50 pounds and occasionally lift and/or move more than 100 pounds with assistance.

SUPERVISION:

• None

EDUCATION:

• High School Diploma required; Associate’s Degree desirable; and Bachelor’s Degree preferred

EXPERIENCE AND REQUIRED SKILLS:

• 4 - 6 years’ related experience.
• This job requires focusing on multiple critical tasks at the same time with an exceptional attention to detail.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to define problems, collect and analyze data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

To perform this job successfully, an individual should have an in-depth knowledge of pharmaceutical manufacturing, Spreadsheet software and Word Processing software.