Shire Veteran Jobs

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

JOB SUMMARY

The Manufacturing Technician leads others in a variety of complex tasks under general guidance and in accordance

with the manufacturing instruction set inclusive of current GMP/ISO requirements and standards and following all safety

Guidelines of PCI. With general supervision, the technician leads and performs all manufacturing operations including but not limited to work functions in equipment prep, dispensing, dissolution, formulation, purification, aseptic compounding, filling and packaging activities for biopharma and medical device products. Addresses non routine matters.

Utilizes technical knowledge and experience to resolve complex manufacturing problems. Monitors personnel interaction

to ensure proper behaviors. Escalates matters requiring resolution by management. Works with, reviews and revises master production records and standard operating procedures. Trains and guides less experienced personnel. Is a model of the Guardian values and behaviors.

JOB DUTIES –

Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines. Is proactive in identifying safety risks and alerts management to take corrective action. Leads team to successfully and completely accomplish daily tasks Maintains weekly/daily schedule up to date and provides direction to team Accountable for completing daily tasks and reporting and escalating issues to management Works with management to provide a positive culture within operations Mentors less experienced staff in the performance of aseptic techniques Prepares solutions, aseptic filling and labeling of vials under sterile and non-sterile conditions, routine solution and filtration, vial and component preparation and sterilization Assembles, disassembles and operates aseptic filling equipment and lyophilizer equipment in classified cleanroom and controlled non classified environments. Operates vial capper, unloads product from lyophilizers and liquid fill line. Prepares equipment and components for sterilization and Lyophilization Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation, centrifuges, mills equipment. Assists in the formulation and dispensing of product in a clean room environment per SOPs and MBRs Sanitizes production areas and prepare equipment for production Completes, maintains and reviews documentation related to assigned work, including logbooks, batch records, etc. Trains others on the team, and ensures proper training completion within the team prior to assigning tasks Troubleshoot and resolve problems with equipment or processes in the course of performing job duties Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation Identifies, escalates and documents events that deviate from normal operation; perform investigations as needed Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs Performs COP, CIP, and SIP operations to prepare equipment for manufacturing operations Demonstrated understanding of sanitization and sterilization practices (build, clean and sterilize equipment to support production operations Inspire and constantly strive to make PCI a great place to work and respected for the quality of its people and products and clients Successfully participates in media fill/aseptic proficiency test

PROFESSIONAL SKILLS –

• Possesses the skill and aptitude to weigh and measure raw materials and operate basic Benchtop instruments

• Strong ability to plan and prioritize complex activities to meet goals and objectives

• Strong analytical skills to identify risks and prepare balanced decisions

· Excellent organizational, verbal and written communication skills

EXPERIENCE –

• 2 – 4 years in the pharmaceutical or medical device industry finished dose form preferred

• Strong knowledge of asepic techniques and fill finish experience required

• Experience in reviewing and creating controlled documents

EDUCATION –

• Requires a high school diploma

QUALITIES –

• Detail oriented with strong mechanical aptitude

• Positive attitude and strong interpersonal skills to resolve and de-escalate issues.

• Honesty, integrity, respect and courtesy with leadership and peers

• Strong commitment to conducting PCI business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of LSNE products and services

• Resilient, can quickly move forward despite complexities and unexpected events, thrives on challenges to improve skills and abilities

• Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment

PHYSICAL REQUIREMENTS –

• Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.

• Ability to gown and gain entry to controlled manufacturing areas

• Ability to lift, pull or push equipment requiring up to 25-50 lbs of force

• Ability to stand for 6 hours in a production suite

• Ability to work any shift (up to 10 hours) as required dependent on business needs

COMMUNICATIONS & CONTACTS –

• Interacts with cross functional support teams such as Operations, QA, QC, Engineering, R&D, Validation, etc.

MANAGERIAL & SUPERVISORY RESPONSIBILITIES -

• Leads team of manufacturing technicians to complete scheduled activities

• Assists in leading the manufacturing team in the absence of the supervisor with support from upper management.

• Raise any personnel related issues to management for resolution

• Assigns daily tasks

TRAVEL – <10%

SPECIAL NOTE: While the PCI Mfg. Technician roles are essentially the same at all company pharmaceutical manufacturing sites, presently at 25 Commerce Drive Bedford, the extensive product mix creates a highly dynamic, complex and at times a challenging work environment.

Thus operators are expected to be highly resilient and possess the following skills an attributes:

• Ability to adapt to a changing process daily (i.e. Formulations vary depending on client product)

• Able to work under the scrutiny of clients daily

• Expected to be flexible with the process and adjust work hours accordingly

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled