Drug Product Principal Process Engineer Job at PCI Pharma Services (Bedford)

Principal, Packaging Engineering

Lead all aspects of packaging process development, qualification, validation, la...

Location

United States

Salary:

180000.00 - 240000.00 USD / Year

Loyal

Expiration Date

Until further notice

Requirements

Bachelor’s, Master’s, or PhD in Packaging Engineering, Chemical Engineering, Mechanical Engineering, Materials Science, or a related field
10+ years of experience in pharmaceutical or biopharmaceutical packaging engineering, with significant experience supporting commercial or late-stage OSD products
Deep expertise in small molecule, oral solid dosage packaging, including bottling, blister packaging, labeling, serialization, and container–closure systems
Proven success leading packaging process development, scale-up, qualification, and validation (IQ/OQ/PQ)
Strong experience with CDMO/CMO selection, technical transfer, and day-to-day management for packaging operations
Experience supporting commercial packaging operations, including launch readiness and ongoing supply
Demonstrated ability to author packaging sections of regulatory submissions (e.g., Module 3) and respond to packaging-related regulatory questions
Strong understanding of global packaging regulatory expectations (FDA, EMA, ICH), including CR/SF requirements and serialization/traceability standards
Experience with packaging component qualification, compatibility studies, and packaging-related stability requirements
Experience supporting or participating in pre-approval inspections (PAIs) related to packaging

Job Responsibility

Lead packaging process development, scale-up, and optimization for OSD drug products
Drive CDMO/CMO selection, including technical evaluations, audits, contracting, and governance for packaging operations
Develop and refine packaging processes, ensuring robustness, manufacturability, and compliance with regulatory and product requirements
Lead packaging qualification and validation (IQ/OQ/PQ) for launch and commercial readiness
Oversee packaging launch readiness, including artwork, labeling, serialization, child-resistant/senior-friendly requirements, packaging components, and distribution-related packaging needs
Establish and oversee commercial packaging operations, ensuring efficiency, compliance, and long-term supply continuity
Author and contribute to packaging-related sections of regulatory submissions (Module 3), including container closure system documentation, packaging process descriptions, and responses to regulatory queries
Support or participate in PAIs and other regulatory interactions related to packaging
Conduct and oversee packaging component qualification, compatibility studies, and packaging-related stability evaluations
Troubleshoot packaging issues, conduct root-cause investigations, and lead CAPAs

What we offer

Full-coverage health insurance — medical, dental and vision — for you and your dependents
$1,000 home office equipment stipend
$1,200/year learning budget for books, courses, etc.
$250/month wellness budget for gym, cleaners, spa, food, etc.
All 3-day weekends are turned into 4-day weekends
Unlimited vacation and paid holidays
Paw-ternity leave — adopt a dog and get a day off with your new family member
Competitive salary
Company equity options grant for new hires

Fulltime

Principal Scientist – Sterility Assurance

The Principal Scientist – Sterility Assurance within Technical Services / Manufa...

Location

United States , Durham

Salary:

65.00 USD / Hour

Medasource

Expiration Date

Until further notice

Requirements

BS or MS in Microbiology, Biology, Biochemistry, Chemical/Biochemical Engineering, or related scientific discipline
Experience with parenteral drug product manufacturing in a cGMP environment
Experience supporting cGMP operations in areas such as environmental monitoring, sterility assurance validation, contamination control, technical services/MSAT, microbiology laboratory, or quality assurance

Job Responsibility

Provide technical guidance and oversight of aseptic processing activities to operational Process Teams
Support or lead investigations related to sterility assurance, including root cause analysis and remediation
Perform scientific and risk-based evaluations of aseptic processes, environmental monitoring, disinfectant efficacy studies, sanitization programs, and contamination control strategies
Support start-up and tech transfer activities related to sterile manufacturing operations
Analyze microbial, manufacturing, and environmental monitoring data using statistical principles to identify trends, process disruptions, and improvement opportunities
Conduct periodic review of EM program performance and recommend enhancements to ensure a state of control
Use risk management tools to evaluate proposed processes and associated controls for microbial, particulate, and endotoxin risk
Create, execute, review, and/or approve technical documents, including protocols, reports, procedures, and change controls
Support internal and external audits by providing subject-matter expertise in sterile manufacturing, environmental monitoring, and contamination control
Participate in continuous improvement projects aimed at strengthening quality systems and sterility assurance programs

What we offer

Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs
We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays
We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc

Principal IS Business Analyst – Clinical Study Design and Analysis

Amgen is seeking a Principal IS Business Analyst to join the Clinical Study Desi...

Location

United States

Salary:

143358.00 - 173256.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
Master’s degree and 4 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
Bachelor’s degree and 6 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
Associate’s degree and 10 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
High school diploma / GED and 12 years of Life Science/Biotechnology/Pharmacology/Information Systems experience
Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery through technology
Experience with Agile software development methodologies (Scrum)
Excellent communication skills and the ability to interface with senior leadership with confidence and clarity
Experience in writing requirements for the development of modern web applications
Experience in writing user requirements and acceptance criteria in Agile project management systems such as JIRA

Job Responsibility

Collaborates with System Architects and Product Managers to manage business analysis activities, ensuring alignment with engineering and product goals
Captures the voice of the customer to define business processes and product needs
Works with Product Managers and customers to define scope and value for new developments
Collaborates with Engineering and Product Management to prioritize release scopes and refine the product backlog
Ensures non-functional requirements are included and prioritized in the product and release backlogs
Facilitates the breakdown of epics into features and sprint-sized user stories and participates in backlog reviews with the development team
Clearly expresses features in user stories and requirements so all team members and stakeholders understand how they fit into the product backlog
Translates complex business and technological needs into clear, actionable requirements for development teams
Ensures acceptance criteria and definition of done are well-defined
Works closely with UX to align technical requirements, scenarios, and business process maps with user experience designs

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

New

Principal Engineer: Automation - DeltaV

Provide automation technical leadership to a group of Automation Engineers who a...

Location

United States , Holly Springs

Salary:

174409.00 - 202181.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 12 years of Manufacturing Automation Engineering experience
Associate degree and 10 years of Manufacturing Automation Engineering experience
Bachelor’s degree and 6 years of Manufacturing Automation Engineering experience
Master’s degree and 4 years of Manufacturing Automation Engineering experience
Doctorate degree and 2 years of Manufacturing Automation Engineering experience

Job Responsibility

Develop and maintain process control automation solutions using DeltaV Distributed Control System (DCS), Human Machine Interfaces (HMI), and Building Management Systems (BMS)
Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions
Collaborate with business partners to understand how automation can improve workflow and productivity. Synthesize requirements from clients, customers, or end-users to develop the best automation solutions
Provide clear documentation for delivered solutions and processes
work closely with QA partners while supporting computerized systems validation processes in a GxP environment
Maintain Data Integrity Assessments with the current Amgen and Industry standards
Build the business processes to support the project scope in alignment with project timelines
Provide rotational automation on-call support for manufacturing operations
Maintain detailed specification and engineering policies and procedures that affect multiple organizational units
Assist in the cultivation of a robust talent pipeline with diverse capabilities required to thrive in the present and future based on perception of team needs. Partner with the Sr. Manager and HR to recruit, coach, develop, empower, and retain staff. Ensure an ongoing organizational structure capable of adapting to evolving business needs

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Sterility Assurance Scientist

This technical role is responsible for developing and implementing the site’s st...

Location

United States , Concord

Salary:

35.00 USD / Hour

Medasource

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
Demonstrated understanding and experience with scientific principles for manufacturing parenteral drug products under cGMP conditions, including operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance
2+ years (Senior) or 5+ years (Principal) pharmaceutical manufacturing experience in microbiology, sterility assurance, TSMS, or related departments
Technical expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, cleaning/sanitization strategies, and disinfectant efficacy
Knowledge of microbiological media, enumeration techniques, and microorganism isolation and identification (Principal level)
Strong interpersonal, organizational, oral, and written communication skills for cross-functional teamwork and technical documentation
Experience with data analysis, trending, and root cause investigations related to sterility assurance programs
Ability to wear appropriate PPE and gown into cleanroom attire as required for manufacturing or laboratory environments
Flexibility to support varying production schedules, including occasional extended or off-hour work and travel for training and implementation
Ability to perform tasks requiring repetitive motion, standing or walking for long periods

Job Responsibility

Develop and implement sterility assurance programs and contamination control strategies for the site
Provide technical guidance and oversight for environmental monitoring, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization activities, including disinfectant efficacy
Lead or support technical activities related to airflow pattern testing, environmental monitoring performance qualifications (EM PQ), aseptic processing techniques, and facility monitoring
Author, execute, review, and approve technical documents, protocols, and change controls related to sterility assurance programs
Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvement
Apply sterility assurance risk management to evaluate manufacturing processes and associated controls for potential microbial, endotoxin, and particulate contamination
Lead or support root cause investigations and corrective actions for sterility assurance issues
Participate in and provide technical support during internal and external audits
Mentor team members and collaborate with cross-functional teams to achieve business and quality objectives
Support the development and maintenance of cleanroom gowning and aseptic technique strategies/programs

What we offer

Competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs
401k plan that includes a company match and is fully vested after you become eligible
Paid time off, sick time, and paid company holidays
Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

New

Customer Service Representative

We want you to join our team as a Customer Service Representative. If you have t...

Location

United States of America , Pooler

Salary:

Not provided

Circle K

Expiration Date

Until further notice

Requirements

Selling products to customers
Providing excellent customer care
Communication and friendly conversation
Performing at a quick pace while having fun
Working as part of a team to accomplish daily goals
Coming up with great ideas to solve problems
Thinking quickly and offering suggestions
Ability to stand and/or walk for up to 8 hours
Lift and/or carry up to 30 pounds from ground to overhead up to 30 minutes in a shift
Occasionally lift and/or carry up to 60 pounds from ground to waist level

Job Responsibility

Greet customers, run the register, cashier, make purchase suggestions and sometimes work with our food program
Working around the store (inside and out) in many different areas to help maintain our high standards for store appearance and provide fast and friendly service to our customers
Provide regular and predicable onsite attendance
Interact with many customers daily, all while working with a fun, energetic team accomplishing daily tasks around the store

What we offer

Medical, Vision, Dental, & Life Insurance/Short & Long Term Disability
Flexible Schedules
Weekly Pay
Weekly Bonus Potential
Large, Stable Employer
Fast Career Opportunities
Work With Fun, Motivated People
Task Variety
Paid Comprehensive Training
401K With a Competitive Company Match

New

Customer Advisor

Joining us as a Customer Advisor is a great opportunity, whether it’s your first...

Location

United Kingdom , Wetherby

Salary:

12.40 - 14.13 GBP / Hour

Boots

Expiration Date

Until further notice

Requirements

Excel in a varied environment, working at pace
Communicate and listen effectively
Enjoy working as part of a team, promoting a collaborative team dynamic
Know that the little things make the biggest difference for customer interactions
Desire to be a proud brand ambassador for Boots and help our customers find the best products for them

Job Responsibility

Help on the tills
Advise our customers
Work in our back shop
Help our customers and put them at ease
Get to know our in-store offers and schemes and promote them
Help our stores run smoothly
Work with other members in the team to provide a great shopping experience

What we offer

Boots Retirement Savings Plan
Discretionary annual bonus
Generous employee discounts
Enhanced maternity/paternity/adoption leave pay and gift card for anyone expecting or adopting a child
Flexible benefits scheme
Access to free, 24/7 counselling and support through TELUS Health, our Employee Assistance Programme

Fulltime

New

Washrooms Service Technician

Washroom Service Driver. Part of a large, professional, growing hygiene business...

Location

United Kingdom , Exeter

Salary:

25820.00 - 27020.00 GBP / Year

PHSGroup

Expiration Date

Until further notice

Requirements

Full UK manual Driving License for a minimum of 12 months (Subject to insurance requirements), with a maximum of 6 points
Must meet the requirements of an enhanced DBS check
Mandatory vaccinations against Hepatitis B, tetanus/polio

Job Responsibility

Visiting our customers premises in the Exeter area to collect feminine hygiene bins and nappy bins and to replenish other phs products
Once a week you will return to the local depot to unload the waste and stock up on phs products

What we offer

Bonus (OTE £27,020)
23 days annual holiday + bank holidays
Flexible hours and development opportunities
Flexible start and finish times
Most of your routes start and finish from your home
Pension
Enhanced maternity and paternity pay
Life assurance
Discount on household consumables and variety of retailers
13-week training programme

Fulltime

Drug Product Principal Process Engineer

PCI Pharma Services

Location:
United States , Bedford

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 02, 2026

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