Aseptic Production Operator Job in Lakewood 08701, New Jersey Us

Think Globally... Work Locally...

DPT Laboratories, a global leader in pharmaceutical development and manufacturing, is experiencing incredible growth at our Center of Excellence for Sterile and Specialty products in Lakewood.
We are an independent, privately owned company that strives to build long-term partnerships with our employees and our clients. With more than 1,200 employees, we are large enough to provide a professionally rewarding workplace on a global scale but small enough so that individual talents get noticed.
As a contract development and manufacturing organization (CDMO), DPT has a reputation for superior quality, unmatched technical expertise, virtually unlimited manufacturing capabilities and an exemplary regulatory compliance record. We only hire the best and treat our employees as such. We are looking for career-focused individuals who are seeking opportunities for growth in the following position:

DPT is an EOE. Applicants are considered for positions without regard to race, color, religion, sex, national origin, sexual preference, age, marital status, disability, veteran status or other factor not related to the job.

 

Job Requirements:

SUMMARY

Working in a clean room environment, operate line equipment to meet product specifications and production requirements and document same in accordance with all SOPs and cGMP requirements.  Must be capable of performing as a Operator 1, Operator 2, or Utility Technician when called upon to do so.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  1. Operate all of the line equipment, typically equipment for forming, filling, closing, labeling, preparation of components and packaging of the product, as defined in related SOPs, work instructions and the Fill and Package Record. Check documentation for required Expiration and Date codes and set up the Encoding Equipment, this equipment currently includes ink jet and laser encoders.
  2. Clean the operating equipment, supporting equipment and work areas and ensure that all equipment and the manufacturing area is kept clean during the course of normal operations, at the end of the shift, and as assigned otherwise. Document cleaning as required
  3. Document all operations and ensure that the documentation is completed according to required frequency, is accurate and neat and conforms to cGMP requirements, including line equipment and environmental monitor pressure gauges.
  4. Ensure that all required product testing and inspection is performed according to the appropriate SOP and/or Fill and Package Record. Any deviations are communicated and recorded as required by the related SOP and/or Fill and Package Record. Perform tests to support other Operators.
  5. Make adjustments to equipment to ensure that product attributes such as fill weights, cap torque and placement of components is maintained
  6. In the performance of daily activities, ensure that safe work practices are employed. Address and report any observations of unsafe behavior or practices immediately and any recommendations for safety improvements to the Line Leader and/or Supervisor.
  7. Ensure that in the performance of daily activities, all applicable cGMPs are employed. Immediately address and report to the Line Leader, Quality Assurance or the Production Supervisor any behavior or practice that is not cGMP compliant. Maintain knowledge of cGMP by attending required training sessions. 
  8. Share operational knowledge with peers, new-hires, contingency staff members, and newly-appointed operators, as needed, to maintain efficiencies and cGMP compliance.
  9. Actively participate in line clearance and set up activities as defined in the related SOPs and Fill and Package Records. These activities include as examples, equipment set up, code set up, product inspections, component verification, cleaning, reconciliation, component and material removal and documentation.
  10. Participate in team efforts to improve our work environment, product quality, efficiencies, and other initiatives identified as being beneficial to our business.
  11. Live the DPT Core Values of Integrity, Dignity, Perseverance and Trust

 

SUPERVISORY RESPONSIBILITIES: none

Competencies

QUALIFICATIONS

EDUCATION and/or EXPERIENCE: Level 3: High school diploma or general education degree (GED); and at least 2 years aseptic experience; or equivalent combination of education and experience.
LANGUAGE SKILLS Level 3: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals in English. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization, Peers, Line Leaders, Supervisors, and Department Management

MATHEMATICAL SKILLS:  Level 2: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

 

REASONING ABILITY: Level 3: 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

Computer Skills

Certifications, LicenSes, RegIstrations: none

 

Other Skills and Abilities:

 

Other qualIfications

Maintain qualifications to work in an aseptic environment, including maintaining aseptic gowning qualification. 

Maintain qualifications to work in DEA and ISO defined areas, including DEA clearance.

 

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.

           Stand more than 2/3

            Walk up to 2/3

            Sit, less than 1/3

            Use hands, fingers or feet, more than 2/3

            Reach with hands and arms, more than 2/3

            Balance, up to 2/3

            Stoop, kneel, crouch, or crawl, less than 1/3

            Talk or hear, more than 2/3

            Taste or smell, up to 2/3

            Lift up to ______ lbs

            Must have clear vision range 20in, peripheral vision, and color vision

 

 

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.

 

Wet or humid conditions (non-weather): Yes

Work near moving mechanical parts:Yes

Work in high, precarious places: no

Fumes or airborne particles: Yes

Toxic or caustic chemicals: Yes

Outdoor weather conditions: no

Extreme cold (non-weather): no

Extreme heat (non-weather): no

Risk of electrical shock: no

Work with explosives: no

Risk of radiation: no

Vibration: no

Click Here To Apply
http://dptlabs.hua.mytalentlink.hrdpt.com/pm_module/cgi-bin/click.cgi?job_id=97site_id=35