Manufacturing Technician (Pharma/Biotech)

Ramsay Testing Onsite is Required for these roles! Testing onsite is typically every Tuesday in Fort Washington, PA

Information about shifts and hours:

12 hour day shift
6 am to 6:30 pm for processing
6:15 am to 6:45 pm for packaging

12-hour night shift
6 pm to 6:30 am for processing
6:15 pm to 6:45 pm for packaging

The schedule for all groups is a 2-2-3-2-2-3 rotation
- Two days on, Two days off, Three days on, Two days off, Two days on, Three days off

Every other weekend the work over the first 3 days, every other weekend is 3 days off

Manufacturing Contract Associate I (PROCESSING and PACKAGING) (3 Day Shift / 3 Night Shift)

• Under moderate supervision, perform all responsibilities necessary to operate, troubleshoot, set up, adjust, repair and maintain equipment and execute the manufacturing processes.
• Perform a variety of tasks including but not limited to process execution and monitoring to assure product quality and manufacturing throughput.
• Perform routine cleaning, housekeeping and non-routine maintenance with adherence to all safety, environmental and quality policies and procedures.
• This role will also move material and product to and from work centers within the manufacturing site.

Responsibilities:

Under limited supervision and in accordance with all applicable federal, state and local

laws/regulations, the Companies’ policies, procedures and guidelines, this position:

Ensure quality and compliance in all my actions by:

• Attend GMP training on the schedule designated for my role and as appropriate for my role
• Adhere to strict compliance with procedures applicable to my role.
• Exercise the highest level of integrity in the tasks that I perform
• Work with the team to ensure all aspects of the business remain compliant and in an audit ready state
• In a timely and prompt manner, identify report and seek correction for deviations noted in my workplace.
• Embrace a behavior of employee involvement and commitment to doing the job right the first time
• Material Handling, Staging, Order, Return and Good Receipt
• Perform a combination of manual tasks including but not limited to feeding, dispensing, charging, mixing, sorting, inspecting, assembling, and picking.
• Execute the manufacturing and packaging operation with an adequate supply of components using mechanical apparatus, automated equipment and manual processes.
• Accurately complete paperwork and electronic transactions for all documentation requirements including but not limited to SAP transactions, batch record steps and paper and electronic logbooks.
• Perform the final checks and verifications for operations as indicated in the batch records and SOPs
• Order and receive material and perform the required identification and use ( i.e. RFI system and basic SAP)
• Operate forklift, manual and motorized pallet jacks. Maintain proper inventory levels of clean tools including ancillary equipment, pallets and containers.
• Manage the removal of waste and execute equipment cleaning and housekeeping operations in accordance to policies and procedures.
• Partner with supervision to ensure daily requirements are met.
• Dispensing, Compounding, Mixing, and Packaging
• Provide communication for product quality impact in case of deviations and provide the proper escalation to direct supervisor.
• Manufacturing first line operation SME in deviation events and product quality assessments.
• Able to read and apply instruction from paper or electronic batch record. Using basic knowledge of mathematics and simple chemistry, measure or weigh required quantities of raw materials.
• This may include the calculation to adjust dispensed quantity based on material potency as per batch record and SOP directives.
• Accurately document quantities dispensed and charged.
• Coordinate with engineering and management to validate new equipment, tooling, system controls, and validate new product codes.
• Support numerous production line activities such as line tests, qualifications, validation, and improvements.
• Drive OEE including the identification of opportunities to improve production and efficiency in a compliant safe manner.
• Complete other ad-hoc tasks as required.

Equipment Cleaning

• Load, operate and unload the automated washers as per procedures.
• Disassemble/assemble equipment to facilitate cleaning.
• Perform manual cleaning of ancillary equipment, room/suite, bulk truck sampling device, packaging line, and transfer equipment.
• Utilize control system to clean major equipment (CIP/COP).
• Complete visual verification of cleaning and document these steps in the appropriate system.

Housekeeping

• Perform general housekeeping activities at the expected level to comply with cGMP and EHS requirements.
• Perform periodic cleaning to maintain room/zone requirement as per applicable procedures.
• Document cleaning as required in the appropriate system.
• IPC Testing and Samples
• Checks, samples, test material and in process product controls using basic knowledge of chemistry, mathematics and makes adjustments according to the validation parameters for the specific product and process.
• Provide first line of assessment for product quality impact in case of deviation and provide the proper escalation to direct supervisor.
• Primary Manufacturing first line operation SME in deviation event and product quality assessment
• Report deviations and escalate to supervision. Support deviation and non-conformance investigations.
• Perform required check/sampling and testing as per batch record and SOP directives

Computerized Systems Knowledge

• Trained to the role in which you are assigned as required for your job function in the applicable systems
• Utilize MS office and other systems to improve business effectiveness
• Working knowledge of ERP and MES systems.

Product Knowledge

• Have knowledge of the product family, product size and put-up, product critical characteristics (i.e. color, viscosity) and basic understanding and knowledge of the product composition (i.e. active, excipient, components, etc.).
• Have an understanding of the critical parameters associated with all processing steps.

Training

• Partner with the training department to create training materials.
• Participate in all trainings
• Ensure all training is completed on time

Investigations

• Assist in gathering and compiling information.
• Participate in investigations. Compliance- Safety, GMP, Facilities
• Lead areas in ensuring all operations are done in a compliant and safe manner.
• Assist in coordination efforts in case of emergency, as appropriate - spill, fire etc.
• Take necessary action to eliminate and immediately address safety hazards.
• Communicate any observed unsafe behaviors immediately.
• Understand the safety concerns and promote a safety conscious culture within their job function.
• Wear the appropriate PPE when working in manufacturing and other hazardous working
• environments and advocate standards of safety.
• Contribute to and attend all EHS programs as assigned.
• Promptly communicate deficiencies to management.
• Maintain facility in good working condition.
• Works with team to ensure all aspects of business remain compliant.
• Attending GMP training on the schedule designated for the role.
• Adhering to strict compliance with procedures according to the roles and responsibilities.
• In a timely and prompt manner, identify report and seek correction for deviation noted in the workplace.

Documentation Management

• Escalate document errors to supervision for correction or update.
• Perform/assist in the completion, review and documentation of the manufacturing and processes steps as per the batch record and SOP directives.
• Always follow GMP documentation requirements.
• Document all activities GMP requirements.

Leadership

• Assist management through change and transformation.
• Attend meetings as the manufacturing representative as needed.
• Exhibits and lives core values and behaviors.
• Continuously demonstrates all Global Leadership Profile values. Expectations of a Global Leadership
• Profile leader: fairness, honesty, consistent and ethical behaviors, empathy, and people skills.
• Contributes and supports an environment that fosters diversity and inclusion.
• Contributes to a climate of open communication, engagement and ownership within team.
• Provide feedback to site management.
• Builds working relationships.
• Supports strategic and tactical plans in alignment with site’s mission and plans.

Requirements: (List types of requirements and typical years required)

Education:

• High school diploma/secondary education or equivalent and/or associates degree or Bachelor's degree.

Experience:

• 2-4 years of experience in a manufacturing environment, Pharmaceutical/GMP experience preferred.

Physical Demands:

Candidates must be able to meet the physical demand of that this position requires:

• continuous lifting and/or moving from 5 to 25lbs. weight material, and frequent lifting or moving average
• (25-50 lbs) weight material.
• Knowledge, Skills and Abilities: Must have a proven ability to interact with other operators, management,
• and groups inside and outside of Manufacturing. Candidates must have a basic working knowledge of Microsoft
• Word and Excel.

Job Type: Contract

Pay: $21.37 - $23.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Night shift

Education:

• High school or equivalent (Preferred)

Experience:

• manufacturing technician: 3 years (Preferred)
• CGMP: 3 years (Preferred)
• pharma or biotech industry: 2 years (Preferred)

Ability to Commute:

• Fort Washington, PA 19034 (Required)

Work Location: In person