Production Operator (II/III) / Sr. Operator

Job Details:

Role: Production Operator (II/III) / Sr. Operator (Compression, Coating,

Granulation, Encapsulation)

Production Operator II - III (Skilled Operators)- must have OSD

Manufacturing experience.

Experience: 03 - 20 Years

Domain: Pharmaceuticals/Biotechnology/Clinical Research

Location: Chantilly, Virginia

Job Type: Full Time

Salary: USD 47000 – 76000.

Position Description:

Job Summary:

- The Manufacturing/Production Operator performs functions relating to

the processing of drug products, ensuring product compliance to

established current Good Manufacturing Practices (cGMPs), customer

requirements and in conjunction with all Standard Operating

Procedures (SOPs).

- Follows standard procedures to complete tasks, some of which may

vary in scope, sequence, complexity, and timing.

- Applies skills and knowledge to recognize issues and to increase

efficiency, throughput, and quality.

- Understands and runs processes to meet the assigned

standards/routers and fulfils the assigned schedule; when these are

not achieved, participates in the debrief to understand the reasons

why and what needs to be corrected moving forward.

- Assists in troubleshooting process issues. Responsible for the safe

and efficient execution of job duties.

Principle Accountabilities:

- Entry Level & Highly Skilled Pharmaceutical Production/Manufacturing

Operators.

Key Accountabilities:

- Operates pharmaceutical production machinery and follows the

procedures for manufacturing such as weighing, blending, dispensing,

mixing, pellet coating, granulating, drying, milling, blending,

compressing, Encapsulating, Coating, potent compound, etc.

- Meets the requirements for use of manufacturing equipment and other

commonly used equipment per SOPs.

- Executes written SOPs to ensure the purity of materials involved in

the manufacturing process.

- Properly uses all scales, including printouts, zeroing, setting

tares, and daily calibration verification per SOPs.

- Examines manufacturer Product ID Labels, Quality Control release

tags, and Batch Production Record to verify issued/staged raw

materials can be released for production.

- Cleans manufacturing equipment and facilities according to

established SOPs.

- Executes machine changeovers from batch to batch.

- May sample batches for quality testing. Executes required in-process

product quality checks and documents accurately.

- Understands and runs processes to meet the assigned schedule and

standards/routers; when this is not achieved, participates in the

debrief to understand the reasons why and what needs to be corrected

moving forward.

Documentation:

- Completes documentation associated with manufacturing processes

(e.g. batch record, protocols, and logbooks) with detail and

accuracy.

- Meets requirements for entries on all applicable Batch Production

pages, completion and attachment of all dispensary and weight

verification tickets.

- Verifies the manufacturing process on BPR in an accurate and timely

manner.

- Provides status updates and operational challenges on status boards.

Continuous Improvement:

- Assists in troubleshooting process issues; refers deviations from

standard procedure to the supervisor.

- Typically participates in at least one continuous improvement

project of a moderate scope and complexity.

Safety & Compliance:

- Adheres to all cGMP compliance/regulatory mandates and quality

requirements.

- Participates in safety teams, start-up discussions, incident

debriefing sessions, etc.

- Ensures compliance with SOPs, policies and procedures as required by

the Company and regulatory agencies.

- Maintain a clean, organized, work area.

Knowledge & Skills:

- Current Good Manufacturing Practices (cGMP) Food and Drug

Administration (FDA) and other regulatory requirements

- Standard Operating Procedures for process rooms and manufacturing

area.

- GMP compliance in a regulated work environment

- Manufacturing processes and equipment procedures.

Required Skills & Abilities:

- Often referred to as "competencies", leadership attributes, skills,

abilities or behaviours that may be enterprise, functional or job

specific e.g. coaching, negotiation, calibration, technical writing

etc.

- Proficient in running machinery.

- Proficient in (Master Clean/Surface clean) equipment cleaning.

- Proficient in sampling batches.

- Proficient in doing basic set-ups.

- Ability to participate in Continuous Improvement projects.

- Qualified in any of the following manufacturing processes:

- Weighing

- Blending

- Granulation

- Compression

- Coating

- Encapsulation

- Potent Compound.

Experience & Education:

- High School Diploma or equivalent experience

- Any production or retail store experience

- Knowledge of Good Manufacturing Practices (cGMP)

- Looking for Pharmaceutical Glatt, Compression and Pan coating

experience.

Level II Operator:

- HS diploma, GED or College Associate Degree

- Minimum of 2-5 years of pharmaceutical manufacturing experience and

certification in assigned area, as required or proficiency

demonstrated in competencies as required.

- Forklift certification may be required for certain jobs.

Level III Operator:

- HS Diploma, GED or College Associate Degree

- Minimum of 5 years of pharmaceutical manufacturing experience and

certification in assigned area, as required or proficiency

demonstrated in competencies as required.

- Forklift certification may be required for certain jobs.

Knowledge:

- Strong background in solid dose manufacturing specific to

Compression OR Encapsulation OR Coating OR Wurster Coating

- Experience in Pharmaceutical Granulation and Blending experience a

potential plus. Capable of cleaning, setting-up and operating state

of the art equipment including but not limited to : tablet presses

and encapsulation, i.e., Fette 3200i; Fette P 3030; MG2 planeta;

Korsch XM 12.

- Knowledgeable of FDA regulations, GMP, Lean Manufacturing,

Six-Sigma, etc.

- Solid working knowledge and skills in procedures, techniques, tools,

materials and/or equipment needed for the position.

- Basic math, reading, legible writing skills, and problem-solving

abilities.

Physical Requirements/Working Environment

Physical Requirements:

- Must be able to stand for long periods of time (up to 12-hour

shifts), maneuver at least 50 pounds, climb ladders, wear a

respirator and pass associated respirator tests and/or requirements,

and be able to wear all required PPE, including safety glasses, ear

plugs, and safety shoes.

Experience:

- Minimum of 3-7 years OSD/Solid Dose Manufacturing experience is

mandatory (no soft-gels will be considered).

- Candidates from hard candies manufacturing (cough drops,

nutraceuticals) can also be considered.

- Experience in 1 or more of the following areas: Compression

(Tri-Layer Press), Granulation, Encapsulation, Ackley Laser Drill or

"Tablet Printing.

- Wurster Coating, Coating, Fluid Bed Dryers, Bead Tower.

- Capable of cleaning, setting up, dismantling, and operating state of

the art tablet presses and encapsulation, i.e., Fette 3200i; Fette P

3030; MG2 planeta; Korsch XM 12.

- Knowledgeable of FDA regulations, GMP, Lean Manufacturing,

Six-Sigma, etc.

- Level II Operator: Minimum of 3-7 years of OSD pharmaceutical

manufacturing (cGMP) experience

- Level III Operator: Minimum 7 years of pharmaceutical manufacturing

(cGMP) experience.