Technician I Pilot Manufacturing

SUMMARY OF POSITION

The PDTS Technician I perform activities supporting the function in executing daily operations in the Pilot Plant, as well as Research and Development.

This position reports to the Group Leader - Pilot Manufacturing.

RESPONSIBILITIES

The primary responsibilities of this role include the following:

1. Supports Pilot Plant Functions

a. Pilot Plant housekeeping duties.

b. Maintain and monitor Pilot Plant equipment.

c. Practice safe working habits and maintain a safe working environment.

d. Maintain adequate supplies.

e. Accurately execute all GMP documentation including batch records, cleaning records, logbooks, etc.

f. Escalates documentation and process errors, events, and deviations immediately to PDTS Manager/Group Leader and PDTS QA.

g. Operation of equipment in accordance with procedures/documents.

h. Understand the basic theory of operation of equipment (running parameters, quality importance).

i. Perform equipment tear down and set up.

j. Perform equipment - based cleans (M/M, P/P, B/B).

k. Understand and follow safe practices and job aids.

l. Properly lock out equipment and verify zero energy state.

m. Attend Vendor Training as Directed.

n. Effectively work with others (PDTS MFG Team, QA, Documentation Group, Engineers, Vendors, Formulators, etc.)

o. Obtaining qualifications on the assembly/disassembly, operation, and cleaning of equipment in the PDTS areas.

2. Administrative Duties.

a. Maintain Pilot Plant records/files.

b. Order supplies in accordance with company procedures.

QUALIFICATIONS

Successful candidate must have:

1. GED / High School Diploma Required

2. 1 to 3 years of prior Manufacturing Environment Experience or prior Pharmaceutical Experience.

3. Strong oral and written communications skills.

4. Proficient in computer use (Word, Excel, etc.) with the ability to learn new computer applications.

5. Prior CGMP experience and the ability to follow standard operating procedures to perform work function

6. Sound judgment and operates with a sense of urgency in a fast-paced environment.

7. Strong interpersonal skills with the ability to work independently as well as in a team setting.

8. Flexibility to work extended and off shifts as needed.

GMP DECISION-MAKING AUTHORITY

The successful candidate will be required to make GMP decisions and/or input to them on a daily basis. Documentation authoring, review, and approval is a daily event.

We are an EEO Employer.